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CD33 Positive Acute Myelogenous LeukemiaAMLNCT02312037

Expanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients In The USA Without Access To Comparable Or Alternative Therapy

A study testing Antibody Drug Conjugate Chemotherapeutic in people with CD33 Positive Acute Myelogenous Leukemia, run by Pfizer at 142 sites in United States.

No Longer Available

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

An expanded access/compassionate use protocol that allows access to Mylotarg for relapsed/refractory AML CD33 positive patients in the USA. Contact: B1761026@iconplc.com Read more about this study

Who is it for?
Ages 3 months and older
Conditions the study is for
CD33 Positive Acute Myelogenous Leukemia
What is being tested?
Antibody Drug Conjugate Chemotherapeutic
How many people
Not given
Where
142 sitesUnited States
Study dates
Start not givento not given
Phase
Expanded access
Are there results?
None posted in the registry

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 3 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of relapsed/refractory AML (defined as >=5% marrow blasts by morphology), including MDS, with persisting rising blasts and no other comparable or satisfactory alternative therapy available. If bone marrow has <5% blasts by morphology but the patient has evidence of relapse with extra-medullary disease progression. In select cases presenting with conversion of MRD from negative to positive, treatment with GO may be allowed where no alternative treatments are feasible.
  • OR
  • Confirmed diagnosis of relapsed or refractory APL with persisting or rising leukemic burden (either by morphology, cytogenetic analysis or by molecular techniques), and no other comparable or satisfactory alternative therapy available.
  • Documentation that malignant cells express CD33
  • 4) Age >=3 months
  • 5) Adequate non-hematologic organ function

Who cannot join

  • Untreated AML and MDS or AML and MDS in complete remission.
  • Patients with a known history of VOD/SOS.
  • Patients with a known hypersensitivity to Mylotarg or its parts: hP67.6 antibody, calicheamicin derivatives or other ingredients.
  • Participation in other studies involving investigational drug(s) (Phases 1-4) during study participation.

Trial locations and contacts

142 sites in 1 country.

142 sites in 1 country

United States142 sites

  • Alaska Oncology & Hematology, LLC

    Anchorage, Alaska, 99508-2980

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Providence Cancer Center

    Anchorage, Alaska, 99508

  • Fox Valley Hematology & Oncology, SC

    Appleton, Wisconsin, 59413

  • Children's Healthcare of Atlanta at Egleston

    Atlanta, Georgia, 30322

  • The Blood & Marrow Transplant Group Of Georgia

    Atlanta, Georgia, 30342-4790

  • Children's Healthcare of Atlanta at Scottish Rite

    Atlanta, Georgia, 30342

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Children's Blood and Cancer Center

    Austin, Texas, 78723

  • Dell Children's Medical Center of Central Texas

    Austin, Texas, 78723

  • Dell Children's Medical Center

    Austin, Texas, 78723

  • Johns Hopkins University IDS Pharmacy

    Baltimore, Maryland, 21231

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • University of Alabama at Birmingham/Children's of Alabama

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Cancer Center IDS Pharmacy Attn: Lauren Benusa, Pharm D.

    Charlottesville, Virginia, 22903

  • Emily Couric Clinical Cancer Center

    Charlottesville, Virginia, 22903

  • UVA Health System

    Charlottesville, Virginia, 22908

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

  • Investigational Drugs Service Pharmacy, Attn. Judy Pi, PharmD, Ami Patel, PharmD

    Chicago, Illinois, 60637

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • The University of Chicago

    Chicago, Illinois, 60637

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • University Hospitals of Cleveland Rainbow Babies & Children's Hospital

    Cleveland, Ohio, 44106

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • Siteman Cancer Center - West County

    Creve Coeur, Missouri, 63141

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • North Shore Hematology Oncology Associates, P.C.

    East Setauket, New York, 11733

  • El Paso Children's Hospital

    El Paso, Texas, 79905

  • Texas Tech University Health Sciences Center

    El Paso, Texas, 79905

  • Cook Children's Hematology/Oncology Center

    Fort Worth, Texas, 76104

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

  • The West Clinic, P.C. dba West Cancer Center

    Germantown, Tennessee, 38138

  • Cook Children's Hematology/Oncology Center - Grapevine

    Grapevine, Texas, 76051

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Brody School of Medicine at ECU

    Greenville, North Carolina, 27834

  • Vidant Medical Center

    Greenville, North Carolina, 27834

  • Virginia Oncology Associates

    Hampton, Virginia, 23666

  • Milton Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • JDCH pediatric Oncology and Hematology

    Hollywood, Florida, 33021

  • Joe Dimaggio Children's Hospital

    Hollywood, Florida, 33021

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Texas Children's Hospital Attn: Investigational Pharmacy Services

    Houston, Texas, 77030

  • Texas Children's Hospital

    Houston, Texas, 77030

  • Houston Methodist Cancer Center

    Houston, Texas, 77584

  • Indiana University Riley Hospital for Children

    Indianapolis, Indiana, 46202-5225

  • IU Health Pharmacy

    Indianapolis, Indiana, 46202

  • Indiana Blood and Marrow Transplantation - Administrative Offices

    Indianapolis, Indiana, 46237

  • Indiana Blood and Marrow Transplantation

    Indianapolis, Indiana, 46237

  • St.Francis Hospital

    Indianapolis, Indiana, 46237

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207-8426

  • Baptist Medical Center/Wolfson Children's Hospital

    Jacksonville, Florida, 32207

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • East Tennessee Children's Hospital

    Knoxville, Tennessee, 37916

  • UK Healthcare Markey Cancer Center

    Lexington, Kentucky, 40536

  • Children's Hospital Of Los Angeles - University Of Southern California School Of Medicine

    Los Angeles, California, 90027

  • Cardinal Bernardin Cancer Center/Loyola University Medical Center

    Maywood, Illinois, 60153

  • Loyola University Chicago, performing research at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120

  • The West Clinic, P.C. dba West Cancer Center

    Memphis, Tennessee, 38120

  • Banner Pediatric Specialists Hematology/Oncology Clinic

    Mesa, Arizona, 85202

  • Cardon Children's Medical Center.

    Mesa, Arizona, 85202

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 34203

  • Sarah Cannon Center for Blood Cancer

    Nashville, Tennessee, 37203

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Tennessee Oncology - Nashville

    Nashville, Tennessee, 37203

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • The Children's Hospital at TriStar Centennial

    Nashville, Tennessee, 37203

  • TriStar Centennial Medical Center/Sarah Cannon Cener for Blood Cancer

    Nashville, Tennessee, 37203

  • TriStar Centennial Medical Center

    Nashville, Tennessee, 37203

  • TriStar Medical Group Children's Specialist

    Nashville, Tennessee, 37203

  • VA Tennessee Valley Healthcare System - Nashville Campus

    Nashville, Tennessee, 37212

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    Nashville, Tennessee, 37232

  • Vanderbilt University Medical Center - The Vanderbilt Clinic

    Nashville, Tennessee, 37232

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08901

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • c/o Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven

    New Haven, Connecticut, 06510

  • Smilow Cancer Hospital at Yale-New Haven

    New Haven, Connecticut, 06510

  • Yale New-Haven Hospital & Smilow Cancer Center

    New Haven, Connecticut, 06510

  • Yale University

    New Haven, Connecticut, 06520

  • Weill Cornell Medical College - New York-Presbyterian Hospital

    New York, New York, 10021

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Weill Cornell Medical College - New York-Presbyterian Hospital

    New York, New York, 10065

  • Children's Hospital of the King's Daughters

    Norfolk, Virginia, 23507

  • Kaiser Permanente - Oakland Medical Center

    Oakland, California, 94611

  • Kaiser Permanente - Oakland

    Oakland, California, 94611

  • Children's Hospital of Orange County

    Orange, California, 92868

  • Blood and Marrow Transplant Center

    Orlando, Florida, 32804

  • Cancer Institute of Florida

    Orlando, Florida, 32804

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Nemours Children's Hospital

    Orlando, Florida, 32827

  • Fox Valley Hematology & Oncology, SC

    Oshkosh, Wisconsin, 59404

  • Memorial Cancer Institute at Memorial Hospital West

    Pembroke Pines, Florida, 33021

  • Memorial Hospital West

    Pembroke Pines, Florida, 33021

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University (Tju) - Jefferson University Physicians (Jup)

    Philadelphia, Pennsylvania, 19107-4215

  • Thomas Jefferson University, Investigative Drug Service

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office (Clinical)

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office (Regulatory)

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • St. Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

  • Allegheny Health Network, Cancer Institute, West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester Cancer Center Pharmacy

    Rochester, New York, 14642

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Kaiser Permanente - Roseville

    Roseville, California, 95661

  • Huntsman Cancer Hospital

    Salt Lake City, Utah, 84112

  • Huntsman Cancer Institute-University of Utah

    Salt Lake City, Utah, 84112

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113

  • UCSD/ Rady Children's Hospital

    San Diego, California, 92123

  • Kaiser Permanente - Santa Clara

    Santa Clara, California, 95051

  • Swedish Medical Center First Hill, IDS Pharmacy

    Seattle, Washington, 98104

  • Seattle Children's IDS Pharmacy - Attn. Laura Winter

    Seattle, Washington, 98105

  • Seattle Children's

    Seattle, Washington, 98105

  • Lisa Nakatsu, RPh

    Seattle, Washington, 98122

  • The West Clinic, P.C. dba West Cancer Center

    Southaven, Mississippi, 38671

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Washington University Infusion Center Pharmacy

    St Louis, Missouri, 63110

  • Washington University School of Medicine, Siteman Cancer Center

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Siteman Cancer Center - South County

    St Louis, Missouri, 63129

  • Johns Hopkins All Children's Hospital IDS Pharmacy

    St. Petersburg, Florida, 33701

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701

  • Johns Hopkins All Children's Outpatient Care Pediatric Hematology/Oncology Department

    St. Petersburg, Florida, 33701

  • H.Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • Yale Medical Group

    Trumbull, Connecticut, 06611

  • Virginia Oncology Associates

    Virginia Beach, Virginia, 23456

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

  • Aurora Health Care, Aurora Cancer Care

    Wauwatosa, Wisconsin, 53226

  • Aurora Health Care, Aurora Cancer Care

    West Allis, Wisconsin, 53227

  • The University of Kansas Cancer Center and Medical Pavilion

    Westwood, Kansas, 66205

  • The University of Kansas Cancer Center and Medical Pavillion

    Westwood, Kansas, 66205

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

  • Nemours - A.I. duPont Hospital for Children

    Wilmington, Delaware, 19803

Other trials in United States

About this study

Official title: GEMTUZUMAB OZOGAMICIN (MYLOTARG (REGISTERED)) EXPANDED ACCESS PROTOCOL FOR TREATMENT OF PATIENTS IN THE UNITED STATES WITH RELAPSED/REFRACTORY ACUTE MYELOGENOUS LEUKEMIA WHO MAY BENEFIT FROM TREATMENT AND HAVE NO ACCESS TO OTHER COMPARABLE/ALTERNATIVE THERAPY

An expanded access/compassionate use protocol that allows access to Mylotarg for relapsed/refractory AML CD33 positive patients in the USA.

Contact: B1761026@iconplc.com

Read the detailed description

Contact:

B1761026@iconplc.com

Being tested
Antibody Drug Conjugate Chemotherapeutic
Keywords
Relapsed CD33 AML, Refractory CD33 AML, Relapsed CD33 APL, Refractory CD33 APL, Relapsed CD33 MDS, Refractory CD33 MDS

What participants receive

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

  • Antibody Drug Conjugate ChemotherapeuticBiological

    Also called Gemtuzumab ozogamicin

    Three Treatment Regimens:

    1. Mylotarg <=9 mg/m2 as a single agent on Day 1 \& 14 of a 28-day cycle for a total of two cycles
    2. Mylotarg in combination with a recognized anthracycline and/or nucleoside-antagonist containing regimen
    3. Mylotarg as monotherapy or in tested combinations with ATRA and/or arsenic trioxide for APL

Timeline

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

  1. First posted9 Dec 2014 (estimated)

Resources

More details

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

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT02312037
Sponsor's protocol ID
B1761026
Acronym
AML
Status last verified
Aug 2019
First submitted
4 Dec 2014
Last updated
20 Aug 2019
Results posted
No

Publications

  • Wang ES, Aplenc R, Chirnomas D, Dugan M, Fazal S, Iyer S, Lin TL, Nand S, Pierce KJ, Shami PJ, Vermette JJ, Abboud CN. Safety of gemtuzumab ozogamicin as monotherapy or combination therapy in an expanded-access protocol for patients with relapsed or refractory acute myeloid leukemia. Leuk Lymphoma. 2020 Aug;61(8):1965-1973. doi: 10.1080/10428194.2020.1742897. Epub 2020 May 20.

    PubMed 32432489

Questions about this trial

What is this clinical trial studying?

A study testing Antibody Drug Conjugate Chemotherapeutic in people with CD33 Positive Acute Myelogenous Leukemia, run by Pfizer at 142 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02312037, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.

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