AzTrials
AzTrials

B Acute Lymphoblastic Leukemia, Philadelphia Chromosome NegativePhase 2NCT03739814

Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia

A Phase 2 study testing Biospecimen Collection, Blinatumomab and Bone Marrow Aspiration in people with B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative and Recurrent B Acute Lymphoblastic Leukemia, run by National Cancer Institute (NCI) at 285 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

This phase II trial studies how well inotuzumab ozogamicin and blinatumomab with or without ponatinib work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back after a period of improvement (recurrent), or does not respond to treatment (refractory). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Blinatumomab and Bone Marrow Aspiration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
285 sitesin 2 countries
Study dates
8 May 2019to 1 Feb 2027
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • STEP 0: Submission of bone marrow aspirate and peripheral blood for MRD analysis is mandatory prior to registration; the bone marrow sample should be from the first aspiration (i.e. first pull). Aspirate needle should be redirected if needed to get first pull bone marrow aspirate. It should be initiated as soon as possible after pre-registration. The specimens should be sent to the HEME Biobank.
  • Lumbar Puncture (Spinal Tap) and Intrathecal Methotrexate:
  • Patients may receive the day 1 of course IA dose of intrathecal (IT) methotrexate during the prior-to-registration lumbar puncture (or the venous line placement) to avoid a second lumbar puncture. If the dose is administered prior to registration, then systemic chemotherapy must begin within 7 days of this IT chemotherapy.
  • STEP 1: Morphologic diagnosis of precursor B-cell acute lymphoblastic leukemia (ALL) based on World Health Organization (WHO) criteria. Patients with Burkitt lymphoma/leukemia are not eligible.
  • STEP 1: CD22-positive disease defined as CD22 expression by >= 20% of lymphoblasts by local hematopathology evaluation.
  • STEP 1: Philadelphia chromosome/BCR-ABL1-negative or Philadelphia chromosome/BCR-ABL1-positive B-cell ALL by cytogenetics, fluorescence in situ hybridization (FISH), and/or polymerase chain reaction (PCR).
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  • STEP 1: No active central nervous system (CNS) leukemia (i.e. only CNS-1 disease allowed). Active CNS leukemia is defined as morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), use of CNS-directed local treatment for active disease within 28 days prior to registration, symptomatic CNS leukemia (i.e. cranial nerve palsies or other significant neurological dysfunction) within the 28 days prior to registration, and/or known asymptomatic parenchymal CNS mass lesions; see below for additional guidance. Prophylactic intrathecal medication alone is not an exclusion.
  • Categories of CNS Involvement for CNS Evaluation Prior to Registration:
  • CNS 1: CSF has < 5 WBC/uL with cytospin negative for blasts; or >= 10 red blood cell (RBC)/uL with cytospin negative for blasts.
  • CNS 2: CSF has < 5 WBC/uL with cytospin positive for blasts; or >= 10 RBC/uL with cytospin positive for blasts; or >= 10 RBC/uL, WBC/uL >= 5 but less than Steinherz/Bleyer algorithm with cytospin positive for blasts (see below).
  • CNS 3: CSF has >= 5 WBC/uL with cytospin positive for blasts; or >= 10 RBC/uL, >= 5 WBC/uL and positive by Steinherz/Bleyer algorithm (see below); or clinical signs of CNS leukemia (such as facial nerve palsy, brain/eye involvement or hypothalamic syndrome). Steinherz/Bleyer Method of Evaluating Initial Traumatic Lumbar Punctures:
  • If the patient has leukemia cells in the peripheral blood and the lumbar puncture is traumatic and contains >= 5 WBC/uL with blasts, the following algorithm should be used to define CNS disease: CSF WBC/CSF RBC > 2 x (Blood WBC/Blood RBC count)
  • STEP 1: Patients with known or suspected testicular involvement by leukemia are allowed provided that the patient receives concomitant scrotal/testicular radiotherapy.
  • Unilateral or bilateral testicular enlargement should be assessed by ultrasound or other imaging technique. Biopsy is recommended if clinical findings are equivocal or suggestive of hydrocele or a non-leukemic mass, but further assessments are per treating physician discretion.
  • STEP 1: Not pregnant and not nursing.
  • This study involves agents that have known genotoxic, mutagenic, and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required.
  • STEP 1: Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
  • STEP 1: No unstable cardiac disease such as myocardial infarction, angina pectoris, uncontrolled heart failure, or uncontrolled cardiac arrhythmia within 6 months of registration.
  • STEP 1: No impaired cardiac function, defined as left ventricular ejection fraction (LVEF) < 45% or New York Heart Association (NYHA) stage III or IV congestive heart failure (CHF).
  • STEP 1: Patients with known human immunodeficiency virus (HIV) infection are eligible if they have been on effective antiretroviral therapy with an undetectable viral load tested within 6 months of registration.
  • STEP 1: Patients with hepatitis B virus (HBV) are eligible only if they meet all the following:
  • On HBV-suppressive therapy.
  • No evidence of active virus.
  • No evidence of HBV-related liver damage.
  • STEP 1: Patients with hepatitis C virus (HCV) are eligible only if they meet all the following:
  • Successfully completed complete-eradication therapy with undetectable viral load.
  • No evidence of HCV-related liver damage.
  • STEP 1: No history of clinically relevant neurologic disorder such as epilepsy, seizure, aphasia, stroke, severe brain injury, structural brain abnormality, benign brain tumor, dementia, Parkinson's disease, movement disorder, cerebellar disease, or other significant CNS abnormalities.
  • STEP 1: No prior additional malignancy (i.e. in addition to ALL) except adequately treated basal- or squamous-cell skin cancer, in situ cervical cancer, stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for >= 2 years.
  • STEP 1: No history of clinically significant ventricular arrhythmia, unexplained non-vasovagal syncope, or chronic bradycardic states such as sinoatrial block or higher degree of atrioventricular block unless a permanent pacemaker has been implanted.
  • STEP 1: No history of chronic liver disease, including cirrhosis.
  • STEP 1: No history of sinusoidal occlusion syndrome/veno-occlusive disease of the liver.
  • STEP 1: No uncontrolled infection or recent history (within 4 months prior to registration) of deep tissue infections such as fasciitis or osteomyelitis.
  • STEP 1: Total bilirubin, serum =< 1.5 x upper limit of normal (ULN)*
  • Except in the event of: 1) Gilbert disease, in which case total bilirubin must be =< 2 x ULN, or 2) elevated bilirubin believed by investigator to be due to leukemic infiltration, in which case total bilirubin must be =< 2 x ULN.
  • STEP 1: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN
  • STEP 1: Creatinine, serum =< 1.5 ULN OR creatinine clearance >= 40 mL/min
  • STEP 1: QT interval by Fridericia's correction formula (QTcF) =< 470 msec
  • COHORT 1: Age >= 60 years.
  • COHORT 1: Diagnosis of Philadelphia chromosome/BCR-ABL1-negative B-cell ALL.
  • COHORT 1: No prior treatment for ALL except a single dose of intrathecal chemotherapy, corticosteroids, hydroxyurea, and/or leukapheresis to reduce peripheral blast count and prevent ALL complications. Allowed therapy may be administered for no more than 14 days and must be completed >= 24 hours prior to the initiation of protocol therapy.
  • COHORT 1: No plan for allogeneic or autologous hematopoietic cell transplantation (HCT).
  • COHORT 2: Age >= 18 years.
  • COHORT 2: Diagnosis of Philadelphia chromosome/BCR-ABL1-negative B-cell ALL.
  • COHORT 2: Relapsed or refractory disease in salvage 1 or 2.
  • COHORT 2: No isolated extramedullary relapse.
  • COHORT 2: Prior allogeneic HCT permitted.
  • COHORT 2: Patients with prior allogeneic HCT must have completed transplantation >= 4 months prior to registration.
  • COHORT 2: Patients with prior allogeneic HCT must have no evidence of graft-versus-host disease and must have completed immunosuppressive therapy >= 30 days prior to registration.
  • COHORT 2: Prior treatment with inotuzumab ozogamicin, blinatumomab, other CD22-directed therapy, or other CD19-directed therapy is not allowed.
  • COHORT 2: Prior treatment with rituximab must be completed >= 7 days prior to registration.
  • COHORT 2: Prior treatment with other monoclonal antibodies must be completed >= 6 weeks prior to registration.
  • COHORT 2: Prior treatment for ALL must be completed >= 14 days prior to registration with the following exceptions: intrathecal chemotherapy, hydroxyurea, corticosteroids, 6-mercaptopurine, methotrexate, vincristine, and/or leukapheresis to reduce circulating absolute lymphoblast count to =< 10,000/uL or prevent complications related to ALL are allowed but must be completed >= 24 hours prior to the initiation of protocol therapy.
  • COHORT 2: Patients should have resolution of any acute non-hematologic toxicities of prior therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 grade =< 1.
  • COHORT 2: Peripheral blood absolute lymphoblast count =< 10,000/uL (treatment allowed as above to reduce blast count to =< 10,000/uL)
  • COHORT 3: Age ≥ 75 years OR age ≥ 18 years AND ineligible for hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (HyperCVAD) regimens
  • COHORT 3: Diagnosis of Philadelphia chromosome/BCR-ABL1-positive B-cell ALL
  • COHORT 3: No prior treatment for ALL except a single dose of intrathecal chemotherapy, corticosteroids, hydroxyurea, BCR-ABL1-targeted tyrosine kinase inhibitor, and/or leukapheresis to reduce peripheral blast count and prevent ALL complications. Allowed non-protocol therapy may be administered for no more than 14 days and must be completed ≥ 24 hours prior to the initiation of protocol therapy.
  • COHORT 3: No chronic, strong CYP3A4 inducers

Who cannot join

None listed.

Trial locations and contacts

285 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

285 sites in 2 countries

United States283 sites, 87 recruiting

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

    Suspended

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

    Suspended

  • OSF Saint Anthony's Health Center

    Alton, Illinois, 62002

    Suspended

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

    Suspended

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

    Suspended

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

    Suspended

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

    Suspended

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

    Suspended

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

    Suspended

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

    Suspended

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

    Suspended

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • PCR Oncology

    Arroyo Grande, California, 93420

    Suspended

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Site Public Contact, 404-778-1868

    William G. Blum

    Recruiting

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

    Site Public Contact, 404-851-7115

    William G. Blum

    Recruiting

  • Mercy Oncology and Hematology - Clayton-Clarkson

    Ballwin, Missouri, 63011

    Suspended

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

    Active, not recruiting

  • Overlake Medical Center

    Bellevue, Washington, 98004

    Suspended

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

    Suspended

  • Saint Charles Health System

    Bend, Oregon, 97701

    Suspended

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

    Suspended

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

    Active, not recruiting

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

    Suspended

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

    Suspended

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

    Suspended

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

    Suspended

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Active, not recruiting

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

    Suspended

  • Loyola Center for Health at Burr Ridge

    Burr Ridge, Illinois, 60527

    Suspended

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

    Suspended

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Mercy Cancer Center - Cape Girardeau

    Cape Girardeau, Missouri, 63703

    Suspended

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

    Suspended

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

    Suspended

  • Caro Cancer Center

    Caro, Michigan, 48723

    Suspended

  • Carson Tahoe Regional Medical Center

    Carson City, Nevada, 89703

    Suspended

  • SIH Cancer Institute

    Carterville, Illinois, 62918

    Suspended

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

    Suspended

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

    Suspended

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

    Suspended

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

    Suspended

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Suspended

  • Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Site Public Contact, 312-695-1301, cancer@northwestern.edu

    Shira N. Dinner

    Recruiting

  • University of Illinois

    Chicago, Illinois, 60612

    Site Public Contact, 312-355-3046

    John G. Quigley

    Recruiting

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

    Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Wendy Stock

    Recruiting

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

    Site Public Contact, 513-584-7698, cancer@uchealth.com

    Emily K. Curran

    Recruiting

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Geoffrey L. Uy

    Recruiting

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Alison K. Conlin

    Recruiting

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

    Suspended

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

    Suspended

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

    Suspended

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Community Cancer Institute

    Clovis, California, 93611

    Active, not recruiting

  • University Oncology Associates

    Clovis, California, 93611

    Active, not recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Site Public Contact, 800-293-5066, Jamesline@osumc.edu

    Gregory K. Behbehani

    Recruiting

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

    Suspended

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Geoffrey L. Uy

    Recruiting

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

    Suspended

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

    Site Public Contact, 313-343-3166, Kkeenan1@hfhs.org

    Christopher M. Reynolds

    Recruiting

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

    Suspended

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

    Site Public Contact, 800-826-4673, becomingapatient@coh.org

    Ibrahim Aldoss

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Active, not recruiting

  • Henry Ford River District Hospital

    East China Township, Michigan, 48054

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Christopher M. Reynolds

    Recruiting

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

    Suspended

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Kareem H. Abdelhadi

    Recruiting

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

    Suspended

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

    Suspended

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

    Site Public Contact, 847-570-2109

    Amy Y. Wang

    Recruiting

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

    Suspended

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

    Suspended

  • Cancer Hematology Centers - Flint

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Christopher M. Reynolds

    Recruiting

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

    Suspended

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Christopher M. Reynolds

    Recruiting

  • Hurley Medical Center

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Christopher M. Reynolds

    Recruiting

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

    Suspended

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

    Suspended

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

    Suspended

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

    Suspended

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

    Suspended

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

    Suspended

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

    Site Public Contact, 847-570-2109

    Amy Y. Wang

    Recruiting

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

    Suspended

  • East Carolina University

    Greenville, North Carolina, 27834

    Suspended

  • Henry Ford Saint John Hospital - Academic

    Grosse Pointe Woods, Michigan, 48236

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Christopher M. Reynolds

    Recruiting

  • Henry Ford Saint John Hospital - Breast

    Grosse Pointe Woods, Michigan, 48236

    Suspended

  • Henry Ford Saint John Hospital - Van Elslander

    Grosse Pointe Woods, Michigan, 48236

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Christopher M. Reynolds

    Recruiting

  • Lehigh Valley Hospital-Hazleton

    Hazleton, Pennsylvania, 18201

    Suspended

  • Cancer and Blood Specialists-Henderson

    Henderson, Nevada, 89052

    Suspended

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052

    Suspended

  • Comprehensive Cancer Centers of Nevada-Horizon Ridge

    Henderson, Nevada, 89052

    Suspended

  • Las Vegas Cancer Center-Henderson

    Henderson, Nevada, 89052

    Suspended

  • Comprehensive Cancer Centers of Nevada-Southeast Henderson

    Henderson, Nevada, 89074

    Suspended

  • Las Vegas Urology - Green Valley

    Henderson, Nevada, 89074

    Suspended

  • Las Vegas Urology - Pebble

    Henderson, Nevada, 89074

    Suspended

  • Oncology Las Vegas - Henderson

    Henderson, Nevada, 89074

    Suspended

  • Urology Specialists of Nevada - Green Valley

    Henderson, Nevada, 89074

    Suspended

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035

    Site Public Contact, 847-570-2109

    Amy Y. Wang

    Recruiting

  • Loyola Medicine Homer Glen

    Homer Glen, Illinois, 60491

    Suspended

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    Deepa Jeyakumar

    Recruiting

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

    Suspended

  • MU Health Care Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

    Suspended

  • Freeman Health System

    Joplin, Missouri, 64804

    Suspended

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

    Suspended

  • Jupiter Medical Center

    Jupiter, Florida, 33458

    Site Public Contact, 561-263-5791, clinicaltrials@jupitermed.com

    Ryan H. Devine

    Recruiting

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Kenneth Byrd

    Recruiting

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

    Suspended

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

    Suspended

  • Kingman Regional Medical Center

    Kingman, Arizona, 86401

    Suspended

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

    Site Public Contact, 858-822-5354, cancercto@ucsd.edu

    James K. Mangan

    Recruiting

  • Providence Regional Cancer System-Lacey

    Lacey, Washington, 98503

    Suspended

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

    Active, not recruiting

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

    Site Public Contact, 516-734-8896

    Bradley H. Goldberg

    Recruiting

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

    Suspended

  • Las Vegas Urology - Pecos

    Las Vegas, Nevada, 89074

    Suspended

  • Desert West Surgery

    Las Vegas, Nevada, 89102

    Suspended

  • OptumCare Cancer Care at Charleston

    Las Vegas, Nevada, 89102

    Suspended

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

    Suspended

  • Hope Cancer Care of Nevada

    Las Vegas, Nevada, 89103

    Suspended

  • Radiation Oncology Centers of Nevada Central

    Las Vegas, Nevada, 89106

    Suspended

  • Urology Specialists of Nevada - Central

    Las Vegas, Nevada, 89106

    Suspended

  • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

    Las Vegas, Nevada, 89109

    Suspended

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109

    Suspended

  • HealthCare Partners Medical Group Oncology/Hematology-San Martin

    Las Vegas, Nevada, 89113

    Suspended

  • Las Vegas Prostate Cancer Center

    Las Vegas, Nevada, 89113

    Suspended

  • Las Vegas Urology - Sunset

    Las Vegas, Nevada, 89113

    Suspended

  • Urology Specialists of Nevada - Southwest

    Las Vegas, Nevada, 89113

    Suspended

  • Radiation Oncology Centers of Nevada Southeast

    Las Vegas, Nevada, 89119

    Suspended

  • Ann M Wierman MD LTD

    Las Vegas, Nevada, 89128

    Suspended

  • Comprehensive Cancer Centers of Nevada - Northwest

    Las Vegas, Nevada, 89128

    Suspended

  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya

    Las Vegas, Nevada, 89128

    Suspended

  • Las Vegas Urology - Cathedral Rock

    Las Vegas, Nevada, 89128

    Suspended

  • Las Vegas Urology - Smoke Ranch

    Las Vegas, Nevada, 89128

    Suspended

  • Oncology Las Vegas - Tenaya

    Las Vegas, Nevada, 89128

    Suspended

  • OptumCare Cancer Care at MountainView

    Las Vegas, Nevada, 89128

    Suspended

  • Urology Specialists of Nevada - Northwest

    Las Vegas, Nevada, 89128

    Suspended

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada, 89135

    Suspended

  • Comprehensive Cancer Centers of Nevada - Town Center

    Las Vegas, Nevada, 89144

    Suspended

  • Comprehensive Cancer Centers of Nevada-Summerlin

    Las Vegas, Nevada, 89144

    Suspended

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada, 89144

    Suspended

  • Las Vegas Cancer Center-Medical Center

    Las Vegas, Nevada, 89148-2405

    Suspended

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

    Suspended

  • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

    Las Vegas, Nevada, 89149

    Suspended

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89169

    Suspended

  • University Cancer Center

    Las Vegas, Nevada, 89169

    Suspended

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89183

    Suspended

  • Beebe Medical Center

    Lewes, Delaware, 19958

    Suspended

  • Hope Cancer Clinic

    Livonia, Michigan, 48154

    Suspended

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • PeaceHealth Saint John Medical Center

    Longview, Washington, 98632

    Suspended

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

    Suspended

  • Henry Ford Saint John Hospital - Macomb Medical

    Macomb, Michigan, 48044

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Christopher M. Reynolds

    Recruiting

  • Henry Ford Warren Hospital - Breast Macomb

    Macomb, Michigan, 48044

    Suspended

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, 53718

    Active, not recruiting

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

    Active, not recruiting

  • North Shore University Hospital

    Manhasset, New York, 11030

    Site Public Contact, 516-734-8896

    Bradley H. Goldberg

    Recruiting

  • Saint Mary's Oncology/Hematology Associates of Marlette

    Marlette, Michigan, 48453

    Suspended

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Kareem H. Abdelhadi

    Recruiting

  • Loyola University Medical Center

    Maywood, Illinois, 60153

    Site Public Contact, 708-226-4357

    Stephanie B. Tsai

    Recruiting

  • Marjorie Weinberg Cancer Center at Loyola-Gottlieb

    Melrose Park, Illinois, 60160

    Suspended

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

    Site Public Contact, 262-257-5100

    Ehab L. Atallah

    Recruiting

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

    Suspended

  • Beebe South Coastal Health Campus

    Millville, Delaware, 19967

    Suspended

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Site Public Contact, 414-805-3666

    Ehab L. Atallah

    Recruiting

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Kareem H. Abdelhadi

    Recruiting

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

    Suspended

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

    Active, not recruiting

  • SSM Health Good Samaritan

    Mount Vernon, Illinois, 62864

    Suspended

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    Christopher M. Reynolds

    Recruiting

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83687

    Suspended

  • Froedtert and MCW Moorland Reserve Health Center

    New Berlin, Wisconsin, 53151

    Site Public Contact, 414-805-0505

    Ehab L. Atallah

    Recruiting

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

    Site Public Contact, 516-734-8896

    Bradley H. Goldberg

    Recruiting

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451

    Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Wendy Stock

    Recruiting

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

    Active, not recruiting

  • NYP/Weill Cornell Medical Center

    New York, New York, 10065

    Active, not recruiting

  • Delaware Clinical and Laboratory Physicians PA

    Newark, Delaware, 19713

    Suspended

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

    Suspended

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Alison K. Conlin

    Recruiting

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

    Suspended

  • Drexel Town Square Health Center

    Oak Creek, Wisconsin, 53154

    Site Public Contact, 414-805-0505

    Ehab L. Atallah

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Zimu Gong

    Recruiting

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

    Suspended

  • Nebraska Medicine-Village Pointe

    Omaha, Nebraska, 68118

    Active, not recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Active, not recruiting

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    Deepa Jeyakumar

    Recruiting

  • Providence Willamette Falls Medical Center

    Oregon City, Oregon, 97045

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Alison K. Conlin

    Recruiting

  • University of Chicago Medicine-Orland Park

    Orland Park, Illinois, 60462

    Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Wendy Stock

    Recruiting

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

    Suspended

  • Hope Cancer Care of Nevada-Pahrump

    Pahrump, Nevada, 89048

    Suspended

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

    Active, not recruiting

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

    Suspended

  • OSF Saint Francis Radiation Oncology at Pekin

    Pekin, Illinois, 61554

    Suspended

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center

    Peoria, Illinois, 61615

    Suspended

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

    Suspended

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

    Suspended

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

    Suspended

  • Valley Radiation Oncology

    Peru, Illinois, 61354

    Suspended

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Active, not recruiting

  • Hope Cancer Center

    Pontiac, Michigan, 48341

    Suspended

  • Michigan Healthcare Professionals Pontiac

    Pontiac, Michigan, 48341

    Suspended

  • Newland Medical Associates-Pontiac

    Pontiac, Michigan, 48341

    Suspended

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Alison K. Conlin

    Recruiting

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Alison K. Conlin

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Active, not recruiting

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

    Suspended

  • Saint Charles Health System-Redmond

    Redmond, Oregon, 97756

    Suspended

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

    Suspended

  • Renown Regional Medical Center

    Reno, Nevada, 89502

    Suspended

  • Saint Mary's Regional Medical Center

    Reno, Nevada, 89503

    Suspended

  • Radiation Oncology Associates

    Reno, Nevada, 89509

    Suspended

  • Valley Medical Center

    Renton, Washington, 98055

    Suspended

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Kareem H. Abdelhadi

    Recruiting

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

    Site Public Contact, 804-628-6430, CTOclinops@vcu.edu

    Keri R. Maher

    Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Completed

  • University of Rochester

    Rochester, New York, 14642

    Site Public Contact, 585-275-5830

    Kristen M. O'Dwyer

    Recruiting

  • Henry Ford Rochester Hospital

    Rochester Hills, Michigan, 48309

    Suspended

  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

    Suspended

  • Phelps Health Delbert Day Cancer Institute

    Rolla, Missouri, 65401

    Suspended

  • MyMichigan Medical Center Saginaw

    Saginaw, Michigan, 48601

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Oncology Hematology Associates of Saginaw Valley PC

    Saginaw, Michigan, 48604

    Suspended

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

    Suspended

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

    Suspended

  • TidalHealth Nanticoke / Allen Cancer Center

    Seaford, Delaware, 19973

    Suspended

  • Pacific Gynecology Specialists

    Seattle, Washington, 98104

    Suspended

  • Swedish Medical Center-Ballard Campus

    Seattle, Washington, 98107

    Suspended

  • Swedish Medical Center-Cherry Hill

    Seattle, Washington, 98122-5711

    Suspended

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122

    Suspended

  • PeaceHealth United General Medical Center

    Sedro-Woolley, Washington, 98284

    Suspended

  • Providence Regional Cancer System-Shelton

    Shelton, Washington, 98584

    Suspended

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

    Suspended

  • Springfield Clinic

    Springfield, Illinois, 62702

    Suspended

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

    Suspended

  • Mercy Medical Center

    Springfield, Massachusetts, 01104

    Suspended

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

    Suspended

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

    Suspended

  • Mercy Infusion Center - Chippewa

    St Louis, Missouri, 63109

    Suspended

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Geoffrey L. Uy

    Recruiting

  • Mercy Hospital South

    St Louis, Missouri, 63128

    Site Public Contact, 314-525-6042, Danielle.Werle@mercy.net

    Jay W. Carlson

    Recruiting

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Geoffrey L. Uy

    Recruiting

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

    Suspended

  • Siteman Cancer Center at Christian Hospital

    St Louis, Missouri, 63136

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Geoffrey L. Uy

    Recruiting

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

    Site Public Contact, 314-251-7066

    Jay W. Carlson

    Recruiting

  • Bhadresh Nayak MD PC-Sterling Heights

    Sterling Heights, Michigan, 48312

    Suspended

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Kareem H. Abdelhadi

    Recruiting

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

    Site Public Contact, 800-862-2215

    Suhu Liu

    Recruiting

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080

    Suspended

  • MyMichigan Medical Center Tawas

    Tawas City, Michigan, 48764

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Saint Luke's Cancer Institute - Twin Falls

    Twin Falls, Idaho, 83301

    Suspended

  • PeaceHealth Southwest Medical Center

    Vancouver, Washington, 98664

    Suspended

  • Providence Saint Mary Regional Cancer Center

    Walla Walla, Washington, 99362

    Suspended

  • Advanced Breast Care Center PLLC

    Warren, Michigan, 48088

    Suspended

  • Henry Ford Health Warren Hospital

    Warren, Michigan, 48093

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Christopher M. Reynolds

    Recruiting

  • Henry Ford Madison Heights Hospital - Breast

    Warren, Michigan, 48093

    Suspended

  • Henry Ford Warren Hospital - GLCMS

    Warren, Michigan, 48093

    Site Public Contact, 313-343-3166, kforman1@hfhs.org

    Christopher M. Reynolds

    Recruiting

  • Macomb Hematology Oncology PC

    Warren, Michigan, 48093

    Suspended

  • Illinois CancerCare - Washington

    Washington, Illinois, 61571

    Suspended

  • Mercy Hospital Washington

    Washington, Missouri, 63090

    Suspended

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

    Site Public Contact, 202-444-2223

    Kimberley Doucette

    Recruiting

  • UI Health Care Mission Cancer and Blood - Waukee Clinic

    Waukee, Iowa, 50263

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Froedtert West Bend Hospital/Kraemer Cancer Center

    West Bend, Wisconsin, 53095

    Site Public Contact, 414-805-0505

    Ehab L. Atallah

    Recruiting

  • Saint Mary's Oncology/Hematology Associates of West Branch

    West Branch, Michigan, 48661

    Suspended

  • University of Cincinnati Cancer Center-West Chester

    West Chester, Ohio, 45069

    Site Public Contact, 513-584-7698, cancer@uchealth.com

    Emily K. Curran

    Recruiting

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Kareem H. Abdelhadi

    Recruiting

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Kenneth Byrd

    Recruiting

  • Christiana Care Health System-Wilmington Hospital

    Wilmington, Delaware, 19801

    Suspended

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

    Site Public Contact, 336-713-6771

    Bayard L. Powell

    Recruiting

  • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

    Yakima, Washington, 98902

    Suspended

  • Providence Regional Cancer System-Yelm

    Yelm, Washington, 98597

    Suspended

  • Huron Gastroenterology PC

    Ypsilanti, Michigan, 48106

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    Ypsilanti, Michigan, 48197

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

Other trials in United States

Puerto Rico2 sites, 2 recruiting

  • Centro Comprensivo de Cancer de UPR

    San Juan, 00927

    Site Public Contact, 888-823-5923, ctsucontact@westat.com

    Luis J. Santos Reyes

    Recruiting

  • San Juan City Hospital

    San Juan, 00936

    Site Public Contact, 787-763-1296

    Luis J. Santos Reyes

    Recruiting

Other trials in Puerto Rico

About this study

Official title: A Phase II Study of Inotuzumab Ozogamicin Followed by Blinatumomab for Ph-Negative, CD22-Positive B-Lineage Acute Lymphoblastic Leukemia in Newly Diagnosed Older Adults or Adults With Relapsed or Refractory Disease

This phase II trial studies how well inotuzumab ozogamicin and blinatumomab with or without ponatinib work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back after a period of improvement (recurrent), or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug, called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving inotuzumab ozogamicin and blinatumomab with or without ponatinib may be effective in treating patients with newly diagnosed, recurrent or refractory CD22 positive B-lineage acute lymphoblastic leukemia.

Read the detailed description

PRIMARY OBJECTIVES:

Ia. For Philadelphia (Ph)-negative B-cell acute lymphoblastic leukemia (ALL), to confirm tolerability of the combination regimen of inotuzumab ozogamicin followed by blinatumomab.

Ib. For Ph-positive B-cell ALL, to confirm tolerability of ponatinib in combination with inotuzumab ozogamicin and blinatumomab.

II. To estimate the 1-year event-free survival of older, transplant-ineligible patients with newly diagnosed, Ph-negative, CD22-positive, B-cell acute lymphoblastic leukemia (ALL) treated with inotuzumab ozogamicin induction followed by blinatumomab consolidation. (Cohort 1) III. To estimate the 1-year event-free survival of patients with relapsed or refractory Ph-negative, CD22-positive, B-cell ALL treated with inotuzumab ozogamicin induction followed by blinatumomab consolidation. (Cohort 2) IV. To determine the feasibility of the regimen in adult patients with CD22-positive, Ph/BCR-ABL1-positive B-cell ALL. (Cohort 3)

SECONDARY OBJECTIVES:

  1. To estimate the median, 1-year, and 3-year overall survival (OS) in all eligible patients. (Cohort 1) II. To estimate the median, 1-year, and 3-year relapse-free survival (RFS) in all eligible patients. (Cohort 1) III. To estimate the median and 3-year event-free survival (EFS) in all eligible patients. (Cohort 1) IV. To estimate the complete response (CR) rate and overall response rate (ORR, defined as complete response [CR] + complete response with incomplete count recovery [CRi]) to inotuzumab ozogamicin followed by blinatumomab (regimen CR rate and ORR). (Cohort 1) V. To estimate the CR rate and ORR (CR + CRi) to inotuzumab ozogamicin induction alone (induction CR and ORR). (Cohort 1) VI. To estimate the minimal residual disease (MRD) negativity rate in subjects achieving a CR or CRi. (Cohort 1) VII. To estimate the treatment-related mortality with this regimen. (Cohort 1) VIII. To describe the safety and tolerability of this regimen. (Cohort 1) IX. To estimate the median, 1-year, and 3-year OS in all eligible patients. (Cohort 2) X. To estimate the median, 1-year, and 3-year RFS in all eligible patients. (Cohort 2) XI. To estimate the median and 3-year EFS in all eligible patients. (Cohort 2) XII. To estimate ORR (CR/CRi and CR/complete response with partial hematologic recovery [CRh]) to blinatumomab in patients with ALL refractory to inotuzumab ozogamicin. (Cohort 2) XIII. To estimate the CR, CRi, and CRh rates at defined time points and cumulatively for the entire regimen. (Cohort 2) XIV. To determine the MRD negativity (< 10^-4) rate at defined time points including prior to allogeneic HCT and cumulatively in patients achieving a CR, CRh, or CRi. (Cohort 2) XV. To determine the allogeneic hematopoietic cell transplantation (HCT) rate in eligible subjects. (Cohort 2) XVI. To estimate the treatment-related mortality with this regimen. (Cohort 2) XVII. To describe the safety and tolerability of this regimen. (Cohort 2) XVIII. To estimate the 24-week complete molecular response rate. (Cohort 3) XIX. To estimate the median, 1-year, and 3-year OS in all eligible patients. (Cohort 3) XX. To estimate the median, 1-year, and 3-year RFS in all eligible patients. (Cohort 3) XXI. To estimate the median and 3-year EFS in all eligible patients. (Cohort 3) XXII. To estimate ORR (CR/CRi and CR/complete response with partial hematologic recovery [CRh]) to blinatumomab in patients with ALL refractory to inotuzumab ozogamicin. (Cohort 3) XXIII. To estimate the CR, CRi, and CRh rates at defined time points and cumulatively for the entire regimen. (Cohort 3) XXIV. To determine the complete molecular response rate at defined time points and cumulatively in patients achieving a CR, CRh, or CRi. (Cohort 3) XXV. To estimate the treatment-related mortality with this regimen. (Cohort 3) XXVI. To describe the safety and tolerability of this regimen. (Cohort 3)

OTHER OBJECTIVE:

  1. Results of the primary analysis will be examined for consistency, while accounting for the stratification factors and/or covariates of baseline quality of life (QOL) and fatigue.

CORRELATIVE SCIENCE OBJECTIVES:

  1. To correlate specific karyotype groups (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters.

II. To correlate specific karyotype groups with response rates, response duration, survival, and cure in patients treated with inotuzumab ozogamicin followed by blinatumomab.

III. To correlate specific karyotype groups with MRD. IV. To determine karyotype changes at relapse and the influence of the type of change (or no change) in karyotype at relapse.

  1. To assess the correlation of quantitative MRD post-induction with inotuzumab ozogamicin and at sequential consolidation time points with blinatumomab with RFS, EFS, and OS.

VI. To correlate the influence of MRD status (detectable versus [vs.] not and as a continuous measure) in relation to EFS, RFS, and OS with other clinical and biological factors (e.g. previously untreated vs. relapsed disease cohorts; age, initial white blood cell [WBC] count, cytogenetics).

VII. To identify genetic variants and predictors of ex vivo resistance. VIII. To identify genetic variants and predictors of MRD. IX. To identify genetic variants and predictors of relapse. X. To determine inter-patient variability in drug sensitivity of adult ALL. XI. To examine the associations of drug sensitivity with host and leukemia molecular features.

XII. To evaluate T-cell populations and T-cell function during therapy using T-cell markers which include the T-cell subset defining markers CD45, CD3, CD4, CD8, CD45RA, CD45RO, CCR7, CD25, CD127, FOXP3, CD 27, CD28, among others, and markers of T cell exhaustion and senescence including CD57, PD-1, Tim-3, LAG-3, TIGIT, CTLA4, CD160, and ICOS among others.

XIII. To evaluate cytokine levels, and compare between patients who attain a CR vs. those with stable or progressive disease.

EXPLORATORY OBJECTIVES:

  1. To estimate the median, 1-year, and 3-year RFS, EFS, and OS in patients achieving a CR/CRi to inotuzumab ozogamicin. (Cohort 1) II. To compare the median, 1-year, and 3-year RFS, EFS, and OS among patients achieving MRD-negative vs. MRD-positive CR/CRi to inotuzumab ozogamicin. (Cohort 1) III. To compare the median, 1-year, and 3-year RFS, EFS, and OS among patients achieving MRD-negative vs. MRD-positive CR/CRi at any time. (Cohort 1) IV. To describe the rate, severity, and timing of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver after limited inotuzumab ozogamicin exposure and identify risk factors for SOS/VOD. (Cohort 1) V. To estimate the rate of cytokine release syndrome in this population. (Cohort 1) VI. To estimate the median, 1-year, and 3-year RFS from time of CR/CRi to inotuzumab ozogamicin in patients receiving inotuzumab ozogamicin followed by blinatumomab and not undergoing allogeneic hematopoietic cell transplantation (HCT). (Cohort 2) VII. To estimate median, 1-year, and 3-year OS after CR/CRi to inotuzumab ozogamicin in patients not undergoing allogeneic HCT. (Cohort 2) VIII. To compare in a non-randomized fashion median, 1-year, and 3-year OS, median, 1-year, and 3-year RFS, cumulative incidence of relapse (CIR), and non-relapse mortality (NRM) between patients achieving CR/CRi and receiving consolidation with or without allogeneic HCT. (Cohort 2) IX. To describe the rate, severity, and timing of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver after limited inotuzumab ozogamicin exposure and identify risk factors for SOS/VOD. (Cohort 2) X. To estimate the rate of cytokine release syndrome in this population. (Cohort 2) XI. To estimate the median, 1-year, and 3-year RFS, EFS, and OS in patients achieving a CR/CRi to inotuzumab ozogamicin. (Cohort 3) XII. To compare the median, 1-year, and 3-year RFS, EFS, and OS among patients with CR/CRi achieving complete molecular response vs. not to inotuzumab ozogamicin. (Cohort 3) XIII. To compare the median, 1-year, and 3-year RFS, EFS, and OS among patients achieving CR/CRi achieving complete molecular response vs. not at any time. (Cohort 3) XIV. To describe the rate, severity, and timing of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver after limited inotuzumab ozogamicin exposure and identify risk factors for SOS/VOD. (Cohort 3) XV. To estimate the rate of cytokine release syndrome in this population. (Cohort 3) XVI. To assess ABL1 mutational patterns at relapse. (Cohort 3)

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT 1: Patients receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day 1, 8, and 15 (Course IA). By the end of Course IA (day 21), patients with adequate ALL cytoreduction continue to Course IB/IC, and patients who fail to achieve ALL cytoreduction continue to Course II. By the end of Course II, patients with CR-CRi to Course IB/IC and Course II continue to Course IIIA, patients without adequate ALL cytoreduction to Course IA or refractory to Course IB/IC but CR/CRi to Course II continue to Course IIIB. Patients undergo bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients undergo lumbar puncture with cerebrospinal fluid sample collection at baseline and may undergo additionally throughout the study.

COHORT 2: Patients receive inotuzumab ozogamicin IV over 1 hour on day 1, 8, and 15 (Course IA). By the end of Course IA (day 21), patients with adequate ALL cytoreduction continue to Course IB/IC, and patients who fail to achieve ALL cytoreduction continue to Course II. Patients with CR/CRi at the end of Course II continue to Course IIIB.

COURSE IB/IC: Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Treatment continues for 1 course (28 days) in the absence of disease progression or unacceptable toxicity.

COURSE II: Patients receive blinatumomab IV continuously on days 1-28 and 43-70. Treatment continues for 1 course (84 days) in the absence of disease progression or unacceptable toxicity.

COURSE IIIA: Patients receive blinatumomab IV continuously on days 1-28 and 43-70. Treatment continues for 1 course (84 days) in the absence of disease progression or unacceptable toxicity.

COURSE IIIB: Patients receive blinatumomab IV continuously on days 1-28, 43-70, and 85-112. Treatment continues for 1 course (126 days) in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients undergo lumbar puncture with cerebrospinal fluid sample collection at baseline and may undergo additionally throughout the study.

COHORT 3:

INDUCTION:

COURSE I: Patients receive ponatinib orally (PO) daily (QD) on day 1-35, dexamethasone PO QD on days 1-7 and 15-21 and methotrexate intrathecally (IT) on day 1, 15 and 29 for 1 course (35 days) in the absence of disease progression or unacceptable toxicity. Patients with CR or CRi continue to consolidation course IIA or end the study treatment to receive allogenic HCT per the treating physician. Patients without CR or CRi with but adequate ALL cytoreduction (defined as ≥ 50% reduction in bone marrow lymphoblasts from the pre-registration bone marrow aspirate/biopsy and/or ≤ 20% marrow cellularity at the end of Course I bone marrow aspirate/biopsy) also proceed to consolidation course IIA. Patients with progression or failure to achieve adequate ALL cytoreduction are removed from study treatment.

CONSOLIDATION:

COURSE IIA: Patients receive ponatinib PO QD on days 1-21, inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 and methotrexate IT on day 1 for 1 course (21 days) in the absence of disease progression or unacceptable toxicity. Patients with CR or CRi continue to consolidation course IIB or end the study treatment to receive allogenic HCT per the treating physician. Patients without CR or CRi and without progressive disease proceed to course IIC. Patients with progression are removed from study treatment.

COURSE IIB/C: Patients receive ponatinib PO QD on days 1-28, inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 and methotrexate IT on day 1 for 1 course (28 days) in the absence of disease progression or unacceptable toxicity. Patients with CR or CRi end the study treatment to receive allogenic HCT per the treating physician. Patients with progression are removed from study treatment. All other patients proceed to course III.

COURSE III: Patients receive ponatinib PO QD on days 1-84 and receive blinatumomab IV continuously on days 1-28 and 43-70. Treatment continues for 1 course (84 days) in the absence of disease progression or unacceptable toxicity. Patients in CR/CRi proceed to course IV. Patients not in CR/CRi are removed from study treatment.

COURSE IV: Patients receive ponatinib PO QD on days 1-84 and receive blinatumomab IV continuously on days 1-28 and 43-70. Treatment continues for 1 course (84 days) in the absence of disease progression or unacceptable toxicity. Patients in CR/CRi proceed to maintenance. Patients not in CR/CRi are removed from study treatment.

MAINTENANCE: Patients receive ponatinib PO QD for 24 months in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients undergo lumbar puncture with cerebrospinal fluid sample collection at baseline and may undergo additionally throughout the study.

After completion of study treatment, patients are followed up every 3 months for 3 years, and then every 6 months for up to 10 years.

Being tested
Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration, Bone Marrow Biopsy, Inotuzumab Ozogamicin
Medical subject headings
Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample and cerebrospinal fluid collection

  • BlinatumomabBiological

    Also called AMG 103, AMG-103, AMG103, Anti-CD19 x Anti-CD3 Bispecific Monoclonal Antibody

    Given IV

  • Bone Marrow AspirationProcedure or surgery

    Undergo bone marrow aspiration

  • Bone Marrow BiopsyProcedure or surgery

    Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow

    Undergo bone marrow biopsy

  • Inotuzumab OzogamicinBiological

    Also called Besponsa, CMC 544, CMC-544, CMC544

    Given IV

  • Lumbar PunctureProcedure or surgery

    Also called LP, Spinal Tap

    Undergo lumbar puncture

  • PonatinibDrug

    Also called AP 24534, AP-24534, AP24534

    Given PO

Study groups in NCT03739814
Study groupRoleWhat they receive
Cohort 1 (inotuzumab ozogamicin, blinatumomab)ExperimentalSee Detailed Description..
Receives: Procedure: Biospecimen Collection; Biological: Blinatumomab; Procedure: Bone Marrow Biopsy; Biological: Inotuzumab Ozogamicin; Procedure: Lumbar Puncture
Cohort 2 (inotuzumab ozogamicin, blinatumomab)ExperimentalSee Detailed Description.
Receives: Procedure: Biospecimen Collection; Biological: Blinatumomab; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Biological: Inotuzumab Ozogamicin; Procedure: Lumbar Puncture
Cohort 3 (inotuzumab ozogamicin, blinatumomab, ponatinib))ExperimentalSee detailed description
Receives: Procedure: Biospecimen Collection; Biological: Blinatumomab; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Biological: Inotuzumab Ozogamicin; Procedure: Lumbar Puncture; Drug: Ponatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival

    Will be defined as time from start of treatment to failure to achieve complete response (CR)/complete response with incomplete count recovery (CRi) after completing Course II of blinatumomab, relapse after CR/CRi, progression on study requiring withdrawal from study therapy, or death from any cause

    Measured: At 1 year

  2. Completion of protocol treatment (cohort 3)

    Feasibility defined as completion of the planned therapy as defined in the protocol. Success rate defined as the proportion of patients who either complete entire protocol treatment or go off protocol treatment due to the disease (e.g., refractory disease, progression, and relapse).

    Measured: Up to 10 years

Secondary outcomes (7)

  1. Overall survival (OS)

    Will be evaluated using the Kaplan-Meier method. A 95% confidence interval for the 1- and 3-year rates will be constructed using a point-wise confidence interval for the survival function based on a log-minus-log transformation. Will also calculate a 95% confidence interval by using a point-wise confidence interval for the survival function based on a log-minus-log transformation.

    Measured: Time from start of study therapy to death from any cause censored at the last known alive date, assessed up to 10 years

  2. Relapse-free survival (RFS)

    Will be evaluated using the Kaplan-Meier method. A 95% confidence interval for the 1- and 3-year rates will be constructed using a point-wise confidence interval for the survival function based on a log-minus-log transformation. Will also calculate a 95% confidence interval by using a point-wise confidence interval for the survival function based on a log-minus-log transformation.

    Measured: Time from first CR/CRi to progressive disease (relapse, treatment discontinuation due to health deterioration) or death, assessed up to 10 years

  3. Event-free survival (EFS)

    Will be evaluated using the Kaplan-Meier method. A 95% confidence interval for the 1- and 3-year rates will be constructed using a point-wise confidence interval for the survival function based on a log-minus-log transformation. Will also calculate a 95% confidence interval by using a point-wise confidence interval for the survival function based on a log-minus-log transformation.

    Measured: Time from start of treatment to failure to achieve CR/CRi after completing Course II of blinatumomab, relapse after CR/CRi, progression on study requiring withdrawal from study therapy, or death from any cause, assessed up to 10 years

  4. Complete and overall response rate

    Point and interval estimates of the rates will be shown using a 95% binomial confidence interval.

    Measured: Up to 10 years

  5. Minimal residual disease negativity

    Measured: Up to 10 years

  6. Complete molecular response

    Defined as negative BCR-ABL1 quantitative real time polymerase chain reaction on bone marrow aspirate in patients in CR/complete response with partial hematologic recovery/CRi.

    Measured: Up to 10 years

  7. Allogeneic hematopoietic cell transplantation rate (Cohort 2)

    Point and interval estimates of the rate will be shown using a 95% binomial confidence interval.

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2018
  2. Study start8 May 2019
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03739814
Sponsor's protocol ID
NCI-2018-02484
Other IDs
NCI-2018-02484, A041703, A041703, U10CA180821
Status last verified
Aug 2026
First submitted
12 Nov 2018
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.

    PubMed 41671463

  • Wieduwilt MJ, Yin J, Kour O, Teske R, Stock W, Escherich C, Yang J, Li Z, Byrd K, Doucette K, Mangan J, Hall S, Mims AS, Jamieson K, Dinner SN, Bseiso AW, Giordano G, Saygin C, Uy GL, Litzow MR, Stone RM. Inotuzumab Ozogamicin Then Blinatumomab for Older Adults With Newly Diagnosed B-Cell ALL: Alliance Study A041703 Cohort 1 Results. J Clin Oncol. 2025 Nov 10;43(32):3526-3535. doi: 10.1200/JCO-25-00307. Epub 2025 Sep 30.

    PubMed 41026957

  • Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704.

    PubMed 35622074

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