B Acute Lymphoblastic LeukemiaPhase 2NCT06124157
A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)
A Phase 2 study testing Biospecimen Collection, Blinatumomab and Bone Marrow Biopsy in people with B Acute Lymphoblastic Leukemia, run by National Cancer Institute (NCI) at 161 sites in 4 countries.
Trial summary
This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute lymphoblastic leukemia (B-ALL). Read more about this study
- Who is it for?
- Ages 366 days to 46 years
- Conditions the study is for
- B Acute Lymphoblastic Leukemia
- What is being tested?
- Biospecimen Collection, Blinatumomab and Bone Marrow Biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 161 sitesin 4 countries
- Study dates
- 30 May 2025to 1 Dec 2030
- 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 366 days to 46 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must be > 365 days and < 18 years (for AIEOP-BFM), > 365 days and < 22 years (for Children's Oncology Group [COG]) and > 365 days and < 46 years (for ALLTogether sites) at the time of enrollment
- Newly-diagnosed Ph+ or ABL-class Ph-like B-ALL. Leukemic blasts must express CD19. ABL-class fusions are defined as rearrangements involving the following genes predicted to be sensitive to imatinib and/or dasatinib: ABL1, ABL2, CSF1R, and PDGFRB
- Evidence of BCR::ABL1 should be documented by a clinically-validated assay prior to study entry on day 15 from the first dose of vinCRIStine during Induction therapy. ABL-class Ph-like B-ALL gene rearrangements should be documented by a clinically-validated assay and enrolled on study by day 1 of Blinatumomab Block 1. Accepted methods of detection include fluorescence in situ hybridization (FISH) using break-apart of colocalization signal probes, singleplex or multiplex reverse-transcription polymerase chain reaction (RT-PCR), whole-transcriptome or panel-based ribonucleic acid (RNA) sequencing (e.g., Hematologic Cancer Fusion Analysis, TruSight RNA Pan-Cancer Panel or equivalent). Confirmation of 5' fusion partner genes is not required for study enrollment
- Patients with Ph+ B-ALL must have previously started Induction therapy, which includes vinCRIStine, a corticosteroid, pegaspargase or calaspargase pegol, with or without anthracycline, and/or other standard cytotoxic chemotherapy
- Patients with Ph+ B-ALL have not received more than 14 days of systemic Induction therapy beginning with the first Induction dose of vinCRIStine
- Patients with ABL-class Ph-like B-ALL must have previously completed 4 or 5 weeks of multiagent Induction chemotherapy (Induction 1A)
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- Patients may have started either imatinib or dasatinib prior to study entry but should have received no more than 14 days of TKI for Ph+ B-ALL or no more than 35 days of TKI for ABL-class Ph-like B-ALL
- Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of ≤ 2 or Karnofsky and Lansky performance scores ≥ 50%. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age
- For pediatric patients (age 1-17 years): a glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m^2, as determined by one of the following methods (must be performed within 7 days prior to enrollment unless otherwise indicated):
- Estimated GFR (eGFR) ≥ 50 mL/min/1.73 m2
- Measured GFR ≥ 50 mL/min/1.73 m^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard
- For adult patients (age 18 years or older): Creatinine clearance ≥ 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on body weight
- Direct bilirubin < 2.0 mg/dL (34.2 micromoles/L) (must be performed within 7 days prior to enrollment unless otherwise indicated)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 10 x upper limit of normal (ULN) (must be performed within 7 days prior to enrollment unless otherwise indicated)
- * Shortening fraction of ≥ 27% by echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy [repeat if necessary]) OR
- Left Ventricular Ejection fraction of ≥ 50% by radionuclide angiogram or echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy [repeat if necessary]) AND
- Corrected QT Interval, QTc < 480mSec (must be obtained within 21 days prior to enrollment and start of protocol therapy [repeat if necessary])
- Note: Repeat echocardiogram and electrocardiogram are not required if they were performed at or after initial ALL diagnosis before study enrollment
Who cannot join
- Known history of chronic myeloid leukemia (CML)
- ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase
- ALL developing after a previous cancer treated with cytotoxic chemotherapy
- Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
- Down syndrome (trisomy 21)
- Pregnancy and breast feeding
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- Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A negative pregnancy test is required for female patients of childbearing potential within 7 days prior to enrollment
- Lactating females who plan to breastfeed their infants
- Sexually active male and female patients of reproductive potential who have not agreed to use an effective contraception method for the duration of treatment according to protocol
- NOTE: Patients who could become pregnant or could father a child must use effective contraception during protocol treatment and for 30 days after the last dose of dasatinib or 14 days after the last dose of imatinib dose or per institutional standard of care for multiagent chemotherapy, whichever is longer
- Prior treatment with TKIs before study entry with the exception of imatinib or dasatinib
- Patients with congenital long QT syndrome, history of ventricular arrhythmias, or heart block
- Patients with known Charcot-Marie-Tooth disease
- Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with central nervous system (CNS) involvement
- Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible. Patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved
- HIV-infected patients are eligible if on effective anti-retroviral therapy that does not interact with planned study agents and with undetectable viral load within 6 months of treatment
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Trial locations and contacts
161 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
161 sites in 4 countries
United States145 sites, 145 recruiting
- Recruiting
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Site Public Contact, 330-543-3193
Erin Wright
- Recruiting
Albany Medical Center
Albany, New York, 12208
Site Public Contact, 518-262-5513
Lauren R. Weintraub
- Recruiting
Presbyterian Hospital
Albuquerque, New Mexico, 87106
Site Public Contact, 505-559-6113, wburman@phs.org
Beeling Armijo
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Jessica M. Valdez
- Recruiting
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Jacob A. Troutman
- Recruiting
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
Site Public Contact, 800-865-1125
Joshua W. Goldman
- Recruiting
Mission Hospital
Asheville, North Carolina, 28801
Site Public Contact, 828-213-7055, NCDV.ResearchRegulatory@HCAHealthcare.com
Douglas J. Scothorn
- Recruiting
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, 30329
Site Public Contact, 404-785-0232, Olivia.Floyd@choa.org
Lauren Raney
- Recruiting
Augusta University Medical Center
Augusta, Georgia, 30912
Site Public Contact, 706-721-2388, ga_cares@augusta.edu
Colleen H. McDonough
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Site Public Contact, 303-764-5056, josh.b.gordon@nsmtp.kp.org
Kelly W. Maloney
- Recruiting
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
Site Public Contact, 512-628-1902, TXAUS-DL-SFCHemonc.research@ascension.org
Shannon M. Cohn
- Recruiting
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Site Public Contact, 410-601-9083
Jason M. Fixler
- Recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Site Public Contact, 410-955-8804, jhcccro@jhmi.edu
Stacy L. Cooper
- Recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Site Public Contact, 301-319-2100
Kip R. Hartman
- Recruiting
Children's Hospital of Alabama
Birmingham, Alabama, 35233
Site Public Contact, 205-638-9285, oncologyresearch@peds.uab.edu
Matthew A. Kutny
- Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Site Public Contact, 208-381-2774, eslinget@slhs.org
Martha M. Pacheco
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Site Public Contact, 877-442-3324
Melissa A. Burns
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Site Public Contact, 800-767-9355, askroswell@roswellpark.org
Lisa Niswander
- Recruiting
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
Site Public Contact, 802-656-8990, rpo@uvm.edu
Jessica L. Heath
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu
Thomas B. Alexander
- Recruiting
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Site Public Contact, 800-804-9376
Joel A. Kaplan
- Recruiting
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu
Brian C. Belyea
- Recruiting
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611
Site Public Contact, 773-880-4562
Loretta S. Li
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Site Public Contact, 312-355-3046
Dipti S. Dighe
- Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Gabrielle Lapping-Carr
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Site Public Contact, 513-636-2799, cancer@cchmc.org
Erin H. Breese
- Recruiting
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
Site Public Contact, 216-844-5437
Duncan S. Stearns
- Recruiting
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Stuart L. Cramer
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Site Public Contact, 614-722-6039, Melinda.Triplet@nationwidechildrens.org
Mark A. Ranalli
- Recruiting
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
Site Public Contact, 361-694-5311, Crystal.DeLosSantos@dchstx.org
Nkechi I. Mba
- Recruiting
Medical City Dallas Hospital
Dallas, Texas, 75230
Site Public Contact, 972-566-5588
Maurizio L. Ghisoli
- Recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Tamra L. Slone
- Recruiting
Dayton Children's Hospital
Dayton, Ohio, 45404
Site Public Contact, 800-228-4055
Jordan M. Wright
- Recruiting
Blank Children's Hospital
Des Moines, Iowa, 50309
Site Public Contact, 515-241-8912, samantha.mallory@unitypoint.org
Samantha L. Mallory
- Recruiting
Children's Hospital of Michigan
Detroit, Michigan, 48201
Site Public Contact, helpdesk@childrensoncologygroup.org
Meret Henry
- Recruiting
Kaiser Permanente Downey Medical Center
Downey, California, 90242
Site Public Contact, 626-564-3455
Robert M. Cooper
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Site Public Contact, 888-275-3853
Jessica M. Sun
- Recruiting
El Paso Children's Hospital
El Paso, Texas, 79905
Site Public Contact, 915-298-5444, ranjan.bista@ttuhsc.edu
Benjamin Carcamo
- Recruiting
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Site Public Contact, 703-208-6650, Stephanie.VanBebber@inova.org
Robin Y. Dulman
- Recruiting
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Samuel J. Milanovich
- Recruiting
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
Site Public Contact, 239-343-5333, molly.arnstrom@leehealth.org
Emad K. Salman
- Recruiting
Cook Children's Medical Center
Fort Worth, Texas, 76104
Site Public Contact, 682-885-2103, CookChildrensResearch@cookchildrens.org
Kenneth M. Heym
- Recruiting
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610
Site Public Contact, 352-273-8010
Brian Stover
- Recruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Catherine A. Long
- Recruiting
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Aniket Saha
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Site Public Contact, 551-996-2897
Jing Chen
- Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Site Public Contact, 860-545-9981
Michael S. Isakoff
- Recruiting
Penn State Children's Hospital
Hershey, Pennsylvania, 17033
Site Public Contact, 717-531-6012
Lisa M. McGregor
- Recruiting
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Site Public Contact, 954-265-1847, OHR@mhs.net
Iftikhar Hanif
- Recruiting
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Site Public Contact, 808-983-6090
Wade T. Kyono
- Recruiting
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
Site Public Contact, 713-798-1354, burton@bcm.edu
Chelsea Vrana
- Recruiting
Riley Hospital for Children
Indianapolis, Indiana, 46202
Site Public Contact, 800-248-1199
Sandeep Batra
- Recruiting
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana, 46260
Site Public Contact, 317-338-2194, research@stvincent.org
Bassem I. Razzouk
- Recruiting
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Site Public Contact, 800-237-1225
Andrew P. Groves
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Site Public Contact, 601-815-6700
Amanda Strobel
- Recruiting
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
Site Public Contact, 302-651-5572, Allison.bruce@nemours.org
Emi H. Caywood
- Recruiting
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Site Public Contact, 816-302-6808, COGResearchGroup@cmh.edu
Keith J. August
- Recruiting
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
Site Public Contact, 865-541-8266
Susan E. Spiller
- Recruiting
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
Site Public Contact, 702-384-0013, research@sncrf.org
Joseph L. Lasky
- Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu
Angela Ricci
- Recruiting
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
Site Public Contact, 859-257-3379
James T. Badgett
- Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
Site Public Contact, 501-364-7373
Michael W. Bishop
- Recruiting
Loma Linda University Medical Center
Loma Linda, California, 92354
Site Public Contact, 909-558-4050
Albert Kheradpour
- Recruiting
Miller Children's and Women's Hospital Long Beach
Long Beach, California, 90806
Site Public Contact, 562-933-5600
Jacqueline N. Casillas
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Site Public Contact, 323-361-4110
Andrew Doan
- Recruiting
Norton Children's Hospital
Louisville, Kentucky, 40202
Site Public Contact, 502-629-5500, CancerResource@nortonhealthcare.org
Michael J. Ferguson
- Recruiting
Covenant Children's Hospital
Lubbock, Texas, 79410
Site Public Contact, 806-725-8657, mbisbee@providence.org
Kishor M. Bhende
- Recruiting
UMC Cancer Center / UMC Health System
Lubbock, Texas, 79415
Site Public Contact, 806-775-8590
Erin K. Barr
- Recruiting
Atrium Health Navicent
Macon, Georgia, 31201
Site Public Contact, 478-633-2152, andrew.weatherall@atriumhealth.org
Sushmita Nair
- Recruiting
Valley Children's Hospital
Madera, California, 93636
Site Public Contact, 559-353-3000, Research@valleychildrens.org
Ruetima Titapiwatanakun
- Recruiting
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
Cathy A. Lee-Miller
- Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Site Public Contact, 305-243-2647
Julio C. Barredo
- Recruiting
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Site Public Contact, 414-955-4727, MACCCTO@mcw.edu
Paul D. Harker-Murray
- Recruiting
NYU Langone Hospital - Long Island
Mineola, New York, 11501
Site Public Contact, 212-263-4432, cancertrials@nyulangone.org
Chana L. Glasser
- Recruiting
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
Site Public Contact, 612-813-5913, pauline.mitby@childrensmn.org
Michael K. Richards
- Recruiting
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
Site Public Contact, 612-624-2620
Peter M. Gordon
- Recruiting
Morristown Medical Center
Morristown, New Jersey, 07960
Site Public Contact, 973-971-5900
Kathryn L. Laurie
- Recruiting
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
Site Public Contact, 615-342-1919
Clinton M. Carroll
- Recruiting
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Site Public Contact, 800-811-8480
Brianna N. Smith
- Recruiting
Jersey Shore Medical Center
Neptune City, New Jersey, 07753
Site Public Contact, 732-776-4240
Jing Chen
- Recruiting
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
Site Public Contact, 732-235-8675
Marissa Botwinick
- Recruiting
Yale University
New Haven, Connecticut, 06520
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Farzana Pashankar
- Recruiting
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040
Site Public Contact, 718-470-3460
Hiren Patel
- Recruiting
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
Site Public Contact, 504-894-5377
Maria C. Velez-Yanguas
- Recruiting
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Site Public Contact, 504-842-8084, Elisemarie.curry@ochsner.org
Craig Lotterman
- Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
Site Public Contact, CancerTrials@nyulangone.org
Elizabeth A. Raetz
- Recruiting
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Site Public Contact, 212-342-5162, cancerclinicaltrials@cumc.columbia.edu
Lewis B. Silverman
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Site Public Contact, 212-639-7592
Kavitha Ramaswamy
- Recruiting
NYP/Weill Cornell Medical Center
New York, New York, 10065
Site Public Contact, 212-746-1848
Jaclyn Rosenzweig
- Recruiting
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
Site Public Contact, 757-668-7243, CCBDCresearch@chkd.org
Melissa S. Mark
- Recruiting
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, 60453
Site Public Contact, 847-723-7570
Rebecca E. McFall
- Recruiting
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
Site Public Contact, 510-428-3264, PedOncRschOAK@ucsf.edu
Karen R. Rabin
- Recruiting
Kaiser Permanente-Oakland
Oakland, California, 94611
Site Public Contact, 877-642-4691, Kpoct@kp.org
Aarati V. Rao
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Rene Y. McNall-Knapp
- Recruiting
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114
Site Public Contact, 402-955-3949
Jill C. Beck
- Recruiting
Children's Hospital of Orange County
Orange, California, 92868
Site Public Contact, 714-509-8646, oncresearch@choc.org
Elyssa M. Rubin
- Recruiting
AdventHealth Orlando
Orlando, Florida, 32803
Site Public Contact, 407-303-2090, FH.Cancer.Research@flhosp.org
Fouad M. Hajjar
- Recruiting
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
Site Public Contact, 321-841-5357, Jennifer.spinelli@orlandohealth.com
Zhongbo Hu
- Recruiting
Nemours Children's Hospital
Orlando, Florida, 32827
Site Public Contact, 302-651-5572, Allison.bruce@nemours.org
Emi H. Caywood
- Recruiting
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304
Site Public Contact, 800-694-0012, ccto-office@stanford.edu
Jay Michael S. Balagtas
- Recruiting
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, 60068
Site Public Contact, helpdesk@childrensoncologygroup.org
Rebecca E. McFall
- Recruiting
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503
Site Public Contact, 973-754-2207, HallL@sjhmc.org
Alissa Kahn
- Recruiting
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504
Site Public Contact, helpdesk@childrensoncologygroup.org
Jeffrey H. Schwartz
- Recruiting
OSF Children's Hospital of Illinois
Peoria, Illinois, 61637
Site Public Contact, 309-624-4945, ChildrensHospitalofIllinois@osfhealthcare.org
Prerna Kumar
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Site Public Contact, 267-425-5544, CancerTrials@email.chop.edu
Sarah K. Tasian
- Recruiting
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Site Public Contact, 215-427-8991
Gregory E. Halligan
- Recruiting
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Site Public Contact, 602-546-0920
Dana B. Salzberg
- Recruiting
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Site Public Contact, 412-692-8570, jean.tersak@chp.edu
Colleen Mathews
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Site Public Contact, 401-444-1488
Bradley DeNardo
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Site Public Contact, 804-628-6430, CTOclinops@vcu.edu
Jordyn R. Griffin
- Recruiting
Carilion Children's
Roanoke, Virginia, 24014
Site Public Contact, 540-266-6238, wpmccarty@carilionclinic.org
Erwood G. Edwards
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Site Public Contact, 855-776-0015
Madeleine O'Keefe
- Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Site Public Contact, 916-734-3089
Marcio H. Malogolowkin
- Recruiting
Primary Children's Hospital
Salt Lake City, Utah, 84113
Site Public Contact, 801-585-5270
Luke D. Maese
- Recruiting
Children's Hospital of San Antonio
San Antonio, Texas, 78207
Site Public Contact, 210-704-2894, bridget.medina@christushealth.org
Julie Voeller
- Recruiting
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
Site Public Contact, 210-575-6240, Vinod.GidvaniDiaz@hcahealthcare.com
Jose M. Esquilin
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Site Public Contact, 210-450-3800, phoresearchoffice@uthscsa.edu
Anne-Marie R. Langevin
- Recruiting
Rady Children's Hospital - San Diego
San Diego, California, 92123
Site Public Contact, 858-966-5934
William D. Roberts
- Recruiting
UCSF Medical Center-Mission Bay
San Francisco, California, 94158
Site Public Contact, 877-827-3222, cancertrials@ucsf.edu
Karen R. Rabin
- Recruiting
Memorial Health University Medical Center
Savannah, Georgia, 31404
Site Public Contact, 912-350-7887, Lorraine.OHara@hcahealthcare.com
James N. Yarnall
- Recruiting
Maine Children's Cancer Program
Scarborough, Maine, 04074
Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org
Eric C. Larsen
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Site Public Contact, 866-987-2000
Sarah E. Leary
- Recruiting
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Site Public Contact, 605-312-3320, OncologyClinicalTrialsSF@SanfordHealth.org
Jordan Fritch-Hanson
- Recruiting
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
Site Public Contact, 800-228-6618, HopeBeginsHere@providence.org
Judy L. Felgenhauer
- Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Site Public Contact, 217-545-7929
Gregory P. Brandt
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Laura G. Schuettpelz
- Recruiting
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Site Public Contact, 314-251-7066
Robin D. Hanson
- Recruiting
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
Site Public Contact, 727-767-4784, Ashley.Repp@jhmi.edu
Jennifer B. Dean
- Recruiting
Stony Brook University Medical Center
Stony Brook, New York, 11794
Site Public Contact, 800-862-2215
Laura E. Hogan
- Recruiting
State University of New York Upstate Medical University
Syracuse, New York, 13210
Site Public Contact, 315-464-5476
Melanie A. Comito
- Recruiting
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405
Site Public Contact, 253-403-1461, research@multicare.org
Robert G. Irwin
- Recruiting
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607
Site Public Contact, 813-357-0849, jennifer.manns@baycare.org
Don E. Eslin
- Recruiting
Scott and White Memorial Hospital
Temple, Texas, 76508
Site Public Contact, 254-724-5407
Nicholas W. McGregor
- Recruiting
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
Site Public Contact, 718-379-6866, eskwak@montefiore.org
Alice Lee
- Recruiting
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606
Site Public Contact, 419-824-1842, PCIOncResearch@promedica.org
Jamie L. Dargart
- Recruiting
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
Site Public Contact, UACC-IIT@uacc.arizona.edu
Monica M. Davini
- Recruiting
New York Medical College
Valhalla, New York, 10595
Site Public Contact, 914-594-3794
Andrew J. Bellantoni
- Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Site Public Contact, 202-444-2223
Caileigh Pudela
- Recruiting
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Site Public Contact, 202-476-2800, OncCRC_OnCall@childrensnational.org
Jeffrey S. Dome
- Recruiting
Saint Mary's Medical Center
West Palm Beach, Florida, 33407
Site Public Contact, 561-822-4745
Matthew D. Ramirez
- Recruiting
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
Site Public Contact, 302-651-5572, Allison.bruce@nemours.org
Emi H. Caywood
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Site Public Contact, 336-713-6771
Sarah Supples
- Recruiting
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
Site Public Contact, 508-856-3216, cancer.research@umassmed.edu
Stefanie R. Lowas
Canada11 sites, 9 recruiting
- Suspended
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
- Recruiting
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Site Public Contact, 780-407-8798, pedsoncologyresearch@ahs.ca
Sarah J. McKillop
- Recruiting
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Site Public Contact, 902-470-8520, Research@iwk.nshealth.ca
Chelsea Ash
- Recruiting
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
Site Public Contact, 905-521-2100
Uma H. Athale
- Recruiting
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, H3H 1P3
Site Public Contact, 514-412-4445, info@thechildren.com
Stephanie Mourad
- Recruiting
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
Site Public Contact, 514-345-4931, yvan.samson@umontreal.ca
Monia Marzouki
- Recruiting
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Québec, G1V 4G2
Site Public Contact, 418-525-4444, rechclinique@crchudequebec.ulaval.ca
Bruno Michon
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, J1H 5N4
Site Public Contact, 819-820-6480, crcinformation.chus@ssss.gouv.qc.ca
Stephanie Vairy
- Recruiting
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Site Public Contact, 416-813-7654, ask.CRS@sickkids.ca
Sumit Gupta
- Suspended
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
- Recruiting
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Site Public Contact, 866-561-1026, ctu_web@cancercare.mb.ca
Stephanie M. Villeneuve
Australia4 sites, 4 recruiting
- Recruiting
John Hunter Children's Hospital
Hunter Regional Mail Centre, New South Wales, 2310
Site Public Contact, (02) 4985 5180
Kristy McCarthy
- Recruiting
Royal Children's Hospital
Parkville, Victoria, 3052
Site Public Contact, 61 3 9345 5656, Jordan.Hansford@rch.org.au
Stacie S. Wang
- Recruiting
Perth Children's Hospital
Perth, Western Australia, 6009
Site Public Contact, helpdesk@childrensoncologygroup.org
Michelle Ng
- Recruiting
Queensland Children's Hospital
South Brisbane, Queensland, 4101
Site Public Contact, 61 7 3068 1111
Christopher J. Fraser
Puerto Rico1 site, 1 recruiting
- Recruiting
University Pediatric Hospital
San Juan, 00926
Site Public Contact, 787-474-0333
Maria E. Echevarria
About this study
Official title: An International Phase 2 Study of Chemotherapy and Tyrosine Kinase Inhibitors With Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-Class Philadelphia Chromosome-Like B-Cell Acute Lymphoblastic Leukemia
This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib and imatinib are in a class of medications called tyrosine kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib or imatinib in combination with standard chemotherapy may work better in treating patients with Ph+ or Ph-like ABL-class B-ALL than dasatinib or imatinib with chemotherapy.
Read the detailed description
PRIMARY OBJECTIVES:
- To estimate the 3-year event free survival (EFS) of children, adolescents, and young adults <25 years old with newly-diagnosed Ph+ (BCR::ABL1-rearranged) B- ALL who are treated with a modified Berlin-Frankfurt-Münster (mBFM) chemotherapy backbone that incorporates three cycles of blinatumomab without traditional consolidation chemotherapy in combination with continuous dasatinib.
II. To estimate the 3-year EFS of children, adolescents, and young adults <25 years old with newly-diagnosed ABL-class Ph-like B-ALL who are treated with a modified BFM chemotherapy backbone that incorporates three cycles of blinatumomab without traditional consolidation chemotherapy in combination with continuous imatinib for those with PDGFRB gene fusions or dasatinib for those without PDGFRB gene fusions.
III. To describe the safety and toxicity profile (infections, mucositis, neurotoxicity, cytokine release syndrome, hypogammaglobulinemia, therapy delays > 14 days, and treatment-related mortality) for patients with Ph+ or ABL-class Ph-like B-ALL treated on this novel chemo-immunotherapy backbone with continuous tyrosine kinase inhibitor (TKI).
SECONDARY OBJECTIVES:
- To estimate the 3-year overall survival (OS) of patients with Ph+ and ABL-class Ph-like B-ALL, respectively.
II. To estimate the 3-year EFS, disease-free survival (DFS), cumulative incidence rates (CIR) of relapse, and treatment related mortality (TRM), and OS of patients with ABL-class Ph-like B-ALL stratified by their underlying ABL-class fusion subtypes.
III. To describe rates of end of consolidation (EOC)/timepoint 2 (TP2) minimal residual disease (MRD) negativity defined as <1x10-4 or <0.01% for patients with Ph+ B-ALL.
IV. To describe rates of EOC/TP2 MRD negativity defined as <1x10-4 or <0.01% for patients with ABL-class Ph-like B-ALL collectively and based on their ABL-class fusion subtypes.
EXPLORATORY OBJECTIVES:
- To describe rates of end of induction (EOI)/timepoint 1 (TP1) bone marrow MRD negativity defined as <1x10-4 or <0.01% with the introduction of the relevant TKI during Induction for patients with Ph+ and ABL-class Ph-like B-ALL, respectively.
II. To describe the outcomes of patients with Ph+ and ABL-class Ph-like B-ALL who are removed from protocol therapy due to Consolidation Failure.
III. To describe the percentage of patients with Ph+ and ABL-class Ph-like B-ALL who continue TKI beyond protocol-prescribed therapy and their outcomes.
IV. To describe the impact of MRD by next-generation sequencing (NGS) at End of Consolidation on outcomes for patients with Ph+ and ABL-class Ph-like B-ALL.
- To describe the clinical characteristics and outcomes of patients with chronic myeloid leukemia-like biology.
VI. To describe the immune function of patients with Ph+ and ABL-class Ph-like B-ALL pre- and post-blinatumomab plus TKI and correlate with treatment response.
VII. To describe the TKI levels in the plasma and cerebrospinal fluid of children with Ph+ and ABL-class Ph-like B-ALL over the treatment course and correlate with outcome VIII. To describe the impact of TKIs and high-dose methotrexate interaction and identify clinical and biologic factors influencing methotrexate clearance.
OUTLINE:
STRATUM I (PH+ B-ALL PATIENTS):
INDUCTION PART I: Patients receive induction chemotherapy on days 1-14 as per standard of care (SOC).
INDUCTION PART II: Patients receive dasatinib PO once daily (QD) on days 15-29, daunorubicin intravenously (IV) over 15 minutes on days 15 and 22, prednisolone or prednisone PO twice daily (BID) on days 15-28, vincristine IV on days 15 and 22, methotrexate intrathecally (IT) on days 15, 22, and 29, and cytarabine IT on days 18 and 25 if central nervous system (CNS)-3 at study entry.
BLINATUMOMAB BLOCK I: Patients receive dexamethasone PO or intravenously (IV) on day 1, blinatumomab IV on days 1-28, dasatinib PO on days 1-35, and methotrexate IT on days 1 and 15 over 5 weeks on study. Patients may undergo radiation therapy in 12 QD fractions.
BLINATUMOMAB BLOCK II: Patients receive dexamethasone PO or IV on day 1, blinatumomab IV on days 1-28, dasatinib PO on days 1-35, and methotrexate IT on days 1 and 15 over 5 weeks on study.
INTERIM MAINTENANCE I: Patients receive dasatinib PO QD until the end of interim maintenance I, mercaptopurine PO QD on days 1-56, vincristine IV on days 8, 22, 36, and 50, methotrexate IT on days 8 and 36, high-dose methotrexate IV over 24 hours on days 8, 22, 36 and 50, and leucovorin PO or IV on days 10, 11, 24, 25, 38, 39, 52 and 53 over 9 weeks on study.
BLINATUMOMAB BLOCK III: Patients receive blinatumomab IV on days 1-28, dasatinib PO QD on days 1-35, and methotrexate IT on day 1 over 5 weeks on study.
DELAYED INTENSIFICATION PART I: Patients receive dasatinib PO QD on days 1-28, methotrexate IT on day 1, dexamethasone PO or IV on days 1-7 and 15-21, doxorubicin IV over 15 minutes on days 1, 8, and 15, vincristine IV on days 1, 8, and 15, and pegaspargase IV or calaspargase pegol IV over 1-2 hours on day 4 over 4 weeks on study.
DELAYED INTENSIFICATION PART II: Patients receive dasatinib PO QD on day 29 until the end of delayed intensification part II, cyclophosphamide IV over 60 minutes on day 29, cytarabine IV over 30 minutes on days 29-32 and 36-39, methotrexate IT on days 29 and 36, thioguanine PO on days 29-42, pegaspargase IV or calaspargase pegol on day 43 and vincristine IV on days 43 and 50 over 5 weeks on study.
INTERIM MAINTENANCE PART II: Patients receive dasatinib PO QD on day 1 until the end of interim maintenance part II, methotrexate IV on days 1, 11, 21, 31, and 41, vincristine IV on 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and pegaspargase IV or calaspargase pegol IV over 1-2 hours on days 2, 22 or 23 over 8 weeks on study.
MAINTENANCE CYCLES I-II: Patients receive dasatinib PO QD on days 1-84, methotrexate IT on days 1 and 29, dexamethasone PO BID or IV on days 1-5, 29-33, and 57-61, mercaptopurine PO on days 1-84, vincristine IV on days 1, 29 and 57, and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 on study.
MAINTENANCE CYCLES III AND SUBSEQUENT CYCLES: Patients receive dasatinib PO QD on days 1-84, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-5, 29-33, and 57-61, mercaptopurine PO on days 1-84, vincristine IV on days 1, 29 and 57, and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 on study. Cycles repeat every 12 weeks for 2 years from the start of Induction therapy in the absence of disease progression or unacceptable toxicity.
STRATUM II (PDGFRB ABL-CLASS FUSIONS):
BLINATUMOMAB BLOCK I: Patients receive dexamethasone PO or IV on day 1, blinatumomab IV on days 1-28, imatinib PO on days 1-35, and methotrexate IT on days 1 and 15 over 5 weeks on study. Patients may undergo radiation therapy in 12 QD fractions.
BLINATUMOMAB BLOCK II: Patients receive dexamethasone PO or IV on day 1, blinatumomab IV on days 1-28, imatinib PO on days 1-35, and methotrexate IT on days 1 and 15 over 5 weeks on study.
INTERIM MAINTENANCE I: Patients receive imatinib PO QD until the end of interim maintenance I, mercaptopurine PO QD on days 1-56, vincristine IV on days 8, 22, 36, and 50, methotrexate IT on days 8 and 36, high-dose methotrexate IV over 24 hours on days 8, 22, 36 and 50, and leucovorin PO or IV on days 10, 11, 24, 25, 38, 39, 52 and 53 over 9 weeks on study.
BLINATUMOMAB BLOCK III: Patients receive blinatumomab IV on days 1-28, imatinib PO QD on days 1-35, and methotrexate IT on day 1 over 5 weeks on study.
DELAYED INTENSIFICATION PART I: Patients receive imatinib PO QD on days 1-28, methotrexate IT on day 1, dexamethasone PO or IV on days 1-7 and 15-21, doxorubicin IV over 15 minutes on days 1, 8, and 15, vincristine IV on days 1, 8, and 15, and pegaspargase IV or calaspargase pegol IV over 1-2 hours on day 4 over 9 weeks on study.
DELAYED INTENSIFICATION PART II: Patients receive imatinib PO QD on day 29 until the end of Delayed Intensification part II, cyclophosphamide IV over 30-60 minutes on day 29, cytarabine IV over 30 minutes on days 29-32 and 36-39, methotrexate IT on days 29 and 36, thioguanine PO on days 29-42, and pegaspargase IV or calaspargase pegol IV on day 43, and vincristine IV on days 43 and 50 over 5 weeks on study.
INTERIM MAINTENANCE II: Patients receive imatinib PO QD until the end of interim maintenance II, methotrexate IV and vincristine IV on days 1, 11, 21, 31 and 41, methotrexate IT on days 1 and 31, and pegaspargase IV or calaspargase pegol IV over 1-2 hours on days 2, 22 or 23 over 8 weeks on study.
MAINTENANCE CYCLES I-II: Patients receive imatinib PO QD on days 1-84, methotrexate IT on days 1 and 29, dexamethasone PO BID or IV on days 1-5, 29-33, and 57-61, mercaptopurine PO on days 1-84, vincristine IV on days 1, 29 and 57, and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 on study.
MAINTENANCE CYCLES III AND SUBSEQUENT CYCLES: Patients receive imatinib PO QD on days 1-84, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-5, 29-33, and 57-61, mercaptopurine PO on days 1-84, vincristine IV on days 1, 29 and 57, and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 on study. Cycles repeat every 12 weeks for 2 years from the start of Induction therapy in the absence of disease progression or unacceptable toxicity.
STRATUM III (NON-PDGFRB ABL-CLASS FUSIONS):
BLINATUMOMAB BLOCK I: Patients receive dexamethasone PO or IV on day 1, blinatumomab IV on days 1-28, dasatinib PO on days 1-35, and methotrexate IT on days 1 and 15 over 5 weeks on study. Patients may undergo radiation therapy in 12 QD fractions.
BLINATUMOMAB BLOCK II: Patients receive dexamethasone PO or IV on day 1, blinatumomab IV on days 1-28, dasatinib PO on days 1-35, and methotrexate IT on days 1 and 15 over 5 weeks on study.
INTERIM MAINTENANCE I: Patients receive dasatinib PO QD until the end of interim maintenance I, mercaptopurine PO QD on days 1-56, vincristine IV on days 8, 22, 36, and 50, methotrexate IT on days 8 and 36, high-dose methotrexate IV over 24 hours on days 8, 22, 36 and 50, and leucovorin PO or IV on days 10, 11, 24, 25, 38, 39, 52 and 53 over 9 weeks on study.
BLINATUMOMAB BLOCK III: Patients receive blinatumomab IV on days 1-28, dasatinib PO on days 1-35, and methotrexate IT on day 1 over 5 weeks on study.
DELAYED INTENSIFICATION PART I: Patients receive dasatinib PO QD on days 1-28, methotrexate IT on day 1, dexamethasone PO or IV on days 1-7 and 15-21, doxorubicin IV over 15 minutes on days 1, 8, and 15, vincristine IV on days 1, 8, and 15, and pegaspargase IV or calaspargase pegol IV over 1-2 hours on day 4 over 4 weeks on study.
DELAYED INTENSIFICATION PART II: Patients receive dasatinib PO QD and methotrexate IT on day 29 until the end of Delayed Intensification part II, cyclophosphamide IV over 30-60 minutes on day 29, cytarabine IV over 30 minutes on days 29-32 and 36-39, methotrexate IT on days 29 and 36, thioguanine PO on days 29-42, pegaspargase IV or calaspargase pegol on day 43 and vincristine IV on days 43 and 50 over 5 weeks on study.
INTERIM MAINTENANCE II: Patients receive dasatinib PO QD until the end of interim maintenance II, methotrexate IV and vincristine IV on days 1, 11, 21, 31 and 41, methotrexate IT on days 1 and 31, and pegaspargase IV or calaspargase pegol IV over 1-2 hours on days 2, 22 or 23 over 8 weeks on study.
MAINTENANCE CYCLES I-II: Patients receive dasatinib PO QD on days 1-84, methotrexate IT on days 1 and 29, dexamethasone PO BID or IV on days 1-5, 29-33, and 57-61, mercaptopurine PO on days 1-84, vincristine IV on days 1, 29 and 57, and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 on study.
MAINTENANCE CYCLES III AND SUBSEQUENT CYCLES: Patients receive dasatinib PO QD on days 1-84, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-5, 29-33, and 57-61, mercaptopurine PO on days 1-84, vincristine IV on days 1, 29 and 57, and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 on study. Cycles repeat every 12 weeks for 2 years from the start of Induction therapy in the absence of disease progression or unacceptable toxicity.
All patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening. Patients also undergo blood and cerebrospinal fluid (CSF) sample collection and bone marrow biopsy throughout the study and as clinically indicated on study.
- Conditions
- B Acute Lymphoblastic Leukemia
- Being tested
- Biospecimen Collection, Blinatumomab, Bone Marrow Biopsy, Calaspargase Pegol, Cyclophosphamide
- 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 and CSF sample collection
BlinatumomabBiological
Also called AMG 103, AMG-103, AMG103, Anti-CD19 x Anti-CD3 Bispecific Monoclonal Antibody
Receive IV
Bone Marrow BiopsyProcedure or surgery
Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow
Undergo bone marrow biopsy
Calaspargase PegolDrug
Also called Asparaginase (Escherichia coli Isoenzyme II), Conjugate with alpha-(((2,5-Dioxo-1-pyrrolidinyl)oxy)carbonyl)-omega-methoxypoly(oxy-1,2-ethanediyl), Asparlas, Calaspargase Pegol-mknl, EZN-2285
Receive IV
CyclophosphamideDrug
Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518
Receive IV
CytarabineDrug
Also called .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
Receive IV or subcutaneously
DasatinibDrug
Also called BMS 354825, BMS-354825, BMS354825, Dasatinib Hydrate
Receive PO
DaunorubicinDrug
Also called Daunomycin, Daunorrubicina, DNR, Leukaemomycin C
Receive IV
DoxorubicinDrug
Also called Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin
Receive IV
Echocardiography TestProcedure or surgery
Also called EC, Echocardiography
Undergo ECHO
ImatinibDrug
Given PO
LeucovorinDrug
Also called Folinic acid
Receive PO or IV
MercaptopurineDrug
Also called 3H-Purine-6-thiol, 6 MP, 6 Thiohypoxanthine, 6 Thiopurine
Receive PO
MethotrexateDrug
Also called Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate
Receive IT or IV or PO
Multigated Acquisition ScanProcedure or surgery
Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan
Undergo MUGA
PegaspargaseDrug
Also called L-Asparaginase with Polyethylene Glycol, Oncaspar, Oncaspar-IV, PEG-Asparaginase
Receive IV or intramuscularly
PrednisoloneDrug
Also called (11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione, .delta.1-Hydrocortisone, Adnisolone, Aprednislon
Receive PO
PrednisoneDrug
Also called .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl
Receive PO
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate
Undergo radiation therapy
ThioguanineDrug
Also called 2-Amino 6MP, 2-Amino-1,7-dihydro-6H-purine-6-thione, 2-Amino-6-mercaptopurine, 2-Amino-6-purinethiol
Receive PO
VincristineDrug
Also called LCR, Leurocristine, VCR, Vincrystine
Receive IV
| Study group | Role | What they receive |
|---|---|---|
| Stratum I (Ph+ ALL) | Experimental | See detailed description Receives: Procedure: Biospecimen Collection; Biological: Blinatumomab; Procedure: Bone Marrow Biopsy; Drug: Calaspargase Pegol; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dasatinib; Drug: Daunorubicin; Drug: Doxorubicin; Procedure: Echocardiography Test; Drug: Leucovorin; Drug: Mercaptopurine; Drug: Methotrexate; Procedure: Multigated Acquisition Scan; Drug: Pegaspargase; Drug: Prednisolone; Drug: Prednisone; Drug: Vincristine |
| Stratum II (PDGFRB ABL-Class fusions) | Experimental | See detailed description. Receives: Procedure: Biospecimen Collection; Biological: Blinatumomab; Procedure: Bone Marrow Biopsy; Drug: Calaspargase Pegol; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Daunorubicin; Drug: Doxorubicin; Procedure: Echocardiography Test; Drug: Imatinib; Drug: Leucovorin; Drug: Mercaptopurine; Drug: Methotrexate; Procedure: Multigated Acquisition Scan; Drug: Pegaspargase; Drug: Prednisolone; Drug: Prednisone; Radiation: Radiation Therapy; Drug: Thioguanine; Drug: Vincristine |
| Stratum III (non-PDGFRB ABL-Class fusions) | Experimental | See detailed description. Receives: Procedure: Biospecimen Collection; Biological: Blinatumomab; Procedure: Bone Marrow Biopsy; Drug: Calaspargase Pegol; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dasatinib; Drug: Daunorubicin; Drug: Doxorubicin; Procedure: Echocardiography Test; Drug: Leucovorin; Drug: Mercaptopurine; Drug: Methotrexate; Procedure: Multigated Acquisition Scan; Drug: Pegaspargase; Drug: Prednisolone; Drug: Prednisone; Radiation: Radiation Therapy; Drug: Thioguanine; Drug: Vincristine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Philadelphia chromosome-positive (Ph+) (BCR::ABL1-rearranged) 3-year event free survival (EFS)
Will be assessed in children, adolescents, and young adults <25 years old with newly-diagnosed Ph+ (BCR::ABL1-rearranged) B acute lymphoblastic leukemia (B-ALL) who are treated with a modified Berlin-Frankfurt-Münster (mBFM) chemotherapy backbone that incorporates three cycles of blinatumomab without traditional consolidation chemotherapy in combination with continuous dasatinib. Will be estimated using the Kaplan-Meier method with standard errors of Peto.
Measured: Time from enrollment to first event, relapse, second malignancy, or death in complete remission, or last contact for those who are event-free, assessed up to 3 years
ABL-class Ph-like B-ALL 3-year event free survival (EFS)
Will be assessed in children, adolescents, and young adults <25 years old with newly-diagnosed ABL-class Ph-like B-ALL who are treated with a modified BFM chemotherapy backbone that incorporates three cycles of blinatumomab without traditional consolidation chemotherapy in combination with continuous imatinib for those with PDGFRB gene fusions or dasatinib for those without PDGFRB gene fusions. Will be estimated using the Kaplan-Meier method with standard errors of Peto.
Measured: Time from enrollment to first event, relapse, second malignancy, or death in complete remission, or last contact for those who are event-free, assessed up to 3 years
Incidence of adverse events
Will assess the safety and toxicity profile (infections, mucositis, neurotoxicity, cytokine release syndrome, hypogammaglobulinemia, therapy delays > 14 days, and treatment-related mortality) for patients with Ph+ or ABL-class Ph-like B-ALL treated on this novel chemo-immunotherapy backbone with continuous tyrosine kinase inhibitor (TKI). Will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.
Measured: Up to 3 years
Secondary outcomes (8)
3-year overall survival (OS)
Will be assessed in patients with Ph+ and ABL-class Ph-like B-ALL, respectively. Will be estimated using the Kaplan-Meier method with standard errors of Peto.
Measured: Time from enrollment to death from any cause or date of last contact for those who are alive, assessed up to 3 years
3-year EFS
Will be estimated using the Kaplan-Meier method with standard errors of Peto.
Measured: Time from enrollment to first event, relapse, second malignancy, or death in complete remission, or last contact for those who are event-free, assessed up to 3 years
3-year disease free survival
Will be estimated using the Kaplan-Meier method with standard errors of Peto.
Measured: Time from end of consolidation/blinatumomab block 2 (TP2) for early responders to first event (relapse, second malignancy, or death in complete remission) or last contact for those who are event-free, assessed up to 3 years
Cumulative incidence rates of relapse
Will be estimated using Gray's method.
Measured: Up to 3 years
Treatment related mortality
Will be estimated at the end of therapy.
Measured: Up to 3 years
OS of patients with ABL-class Ph-like B-ALL
Will be stratified by their underlying ABL-class fusion subtypes.
Measured: Time from enrollment to death from any cause or date of last contact for those who are alive, assessed up to 3 years
Rates of end of Consolidation (EOC)/timepoint 2 (TP2) minimal residual disease (MRD) negativity for patients with Ph+ B-ALL
Defined as <1x10^-4 or <0.01% for patients with Ph+ B-ALL.
Measured: From EOC to TP2
Rates of EOC/TP2 MRD negativity for patients with ABL-class Ph-like B-ALL collectively and based on their ABL-class fusion subtypes
Defined as <1x10^-4 or <0.01% for patients with ABL-class Ph-like B-ALL collectively and based on their ABL-class fusion subtypes.
Measured: From EOC to TP2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start30 May 2025
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Thai Hoa Tran, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124157
- Sponsor's protocol ID
- NCI-2023-09214
- Other IDs
- NCI-2023-09214, AALL2131, AALL2131, U10CA180886
- Status last verified
- Aug 2026
- First submitted
- 8 Nov 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.