Expanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients In The USA Without Access To Comparable Or Alternative Therapy
AML
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
1 other identifier
expanded_access
N/A
1 country
142
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
142 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2014
CompletedFirst Posted
Study publicly available on registry
December 9, 2014
CompletedAugust 20, 2019
August 1, 2019
December 4, 2014
August 17, 2019
Conditions
Keywords
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
- 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
- \) Age \>=3 months
- \) Adequate non-hematologic organ function
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (142)
University of Alabama at Birmingham/Children's of Alabama
Birmingham, Alabama, 35233, United States
Alaska Oncology & Hematology, LLC
Anchorage, Alaska, 99508-2980, United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
Providence Cancer Center
Anchorage, Alaska, 99508, United States
Banner Pediatric Specialists Hematology/Oncology Clinic
Mesa, Arizona, 85202, United States
Cardon Children's Medical Center.
Mesa, Arizona, 85202, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Children's Hospital Of Los Angeles - University Of Southern California School Of Medicine
Los Angeles, California, 90027, United States
Kaiser Permanente - Oakland Medical Center
Oakland, California, 94611, United States
Kaiser Permanente - Oakland
Oakland, California, 94611, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Kaiser Permanente - Roseville
Roseville, California, 95661, United States
UCSD/ Rady Children's Hospital
San Diego, California, 92123, United States
Kaiser Permanente - Santa Clara
Santa Clara, California, 95051, United States
c/o Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, 06510, United States
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, 06510, United States
Yale New-Haven Hospital & Smilow Cancer Center
New Haven, Connecticut, 06510, United States
Yale University
New Haven, Connecticut, 06520, United States
Yale Medical Group
Trumbull, Connecticut, 06611, United States
Nemours - A.I. duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
JDCH pediatric Oncology and Hematology
Hollywood, Florida, 33021, United States
Joe Dimaggio Children's Hospital
Hollywood, Florida, 33021, United States
Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Nemours Children's Clinic
Jacksonville, Florida, 32207-8426, United States
Baptist Medical Center/Wolfson Children's Hospital
Jacksonville, Florida, 32207, United States
Blood and Marrow Transplant Center
Orlando, Florida, 32804, United States
Cancer Institute of Florida
Orlando, Florida, 32804, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Nemours Children's Hospital
Orlando, Florida, 32827, United States
Memorial Cancer Institute at Memorial Hospital West
Pembroke Pines, Florida, 33021, United States
Memorial Hospital West
Pembroke Pines, Florida, 33021, United States
Johns Hopkins All Children's Hospital IDS Pharmacy
St. Petersburg, Florida, 33701, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
Johns Hopkins All Children's Outpatient Care Pediatric Hematology/Oncology Department
St. Petersburg, Florida, 33701, United States
H.Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322, United States
The Blood & Marrow Transplant Group Of Georgia
Atlanta, Georgia, 30342-4790, United States
Children's Healthcare of Atlanta at Scottish Rite
Atlanta, Georgia, 30342, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Investigational Drugs Service Pharmacy, Attn. Judy Pi, PharmD, Ami Patel, PharmD
Chicago, Illinois, 60637, United States
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
The University of Chicago
Chicago, Illinois, 60637, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Cardinal Bernardin Cancer Center/Loyola University Medical Center
Maywood, Illinois, 60153, United States
Loyola University Chicago, performing research at Loyola University Medical Center
Maywood, Illinois, 60153, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Indiana University Riley Hospital for Children
Indianapolis, Indiana, 46202-5225, United States
IU Health Pharmacy
Indianapolis, Indiana, 46202, United States
Indiana Blood and Marrow Transplantation - Administrative Offices
Indianapolis, Indiana, 46237, United States
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, 46237, United States
St.Francis Hospital
Indianapolis, Indiana, 46237, United States
University of Kansas Hospital
Kansas City, Kansas, 66160, United States
The University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, 66205, United States
The University of Kansas Cancer Center and Medical Pavillion
Westwood, Kansas, 66205, United States
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
UK Healthcare Markey Cancer Center
Lexington, Kentucky, 40536, United States
Johns Hopkins University IDS Pharmacy
Baltimore, Maryland, 21231, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
The West Clinic, P.C. dba West Cancer Center
Southaven, Mississippi, 38671, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Washington University Infusion Center Pharmacy
St Louis, Missouri, 63110, United States
Washington University School of Medicine, Siteman Cancer Center
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center - South County
St Louis, Missouri, 63129, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
North Shore Hematology Oncology Associates, P.C.
East Setauket, New York, 11733, United States
Weill Cornell Medical College - New York-Presbyterian Hospital
New York, New York, 10021, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Weill Cornell Medical College - New York-Presbyterian Hospital
New York, New York, 10065, United States
University of Rochester Cancer Center Pharmacy
Rochester, New York, 14642, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Brody School of Medicine at ECU
Greenville, North Carolina, 27834, United States
Vidant Medical Center
Greenville, North Carolina, 27834, United States
University Hospitals of Cleveland Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Milton Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University (Tju) - Jefferson University Physicians (Jup)
Philadelphia, Pennsylvania, 19107-4215, United States
Thomas Jefferson University, Investigative Drug Service
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office (Clinical)
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office (Regulatory)
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134, United States
Allegheny Health Network, Cancer Institute, West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
The West Clinic, P.C. dba West Cancer Center
Germantown, Tennessee, 38138, United States
East Tennessee Children's Hospital
Knoxville, Tennessee, 37916, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Baptist Memorial Hospital
Memphis, Tennessee, 38120, United States
The West Clinic, P.C. dba West Cancer Center
Memphis, Tennessee, 38120, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 34203, United States
Sarah Cannon Center for Blood Cancer
Nashville, Tennessee, 37203, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Tennessee Oncology - Nashville
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203, United States
TriStar Centennial Medical Center/Sarah Cannon Cener for Blood Cancer
Nashville, Tennessee, 37203, United States
TriStar Centennial Medical Center
Nashville, Tennessee, 37203, United States
TriStar Medical Group Children's Specialist
Nashville, Tennessee, 37203, United States
VA Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, 37212, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232, United States
Vanderbilt University Medical Center - The Vanderbilt Clinic
Nashville, Tennessee, 37232, United States
Children's Blood and Cancer Center
Austin, Texas, 78723, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723, United States
Dell Children's Medical Center
Austin, Texas, 78723, United States
El Paso Children's Hospital
El Paso, Texas, 79905, United States
Texas Tech University Health Sciences Center
El Paso, Texas, 79905, United States
Cook Children's Hematology/Oncology Center
Fort Worth, Texas, 76104, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Cook Children's Hematology/Oncology Center - Grapevine
Grapevine, Texas, 76051, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Texas Children's Hospital Attn: Investigational Pharmacy Services
Houston, Texas, 77030, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Houston Methodist Cancer Center
Houston, Texas, 77584, United States
Huntsman Cancer Hospital
Salt Lake City, Utah, 84112, United States
Huntsman Cancer Institute-University of Utah
Salt Lake City, Utah, 84112, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
Cancer Center IDS Pharmacy Attn: Lauren Benusa, Pharm D.
Charlottesville, Virginia, 22903, United States
Emily Couric Clinical Cancer Center
Charlottesville, Virginia, 22903, United States
UVA Health System
Charlottesville, Virginia, 22908, United States
Virginia Oncology Associates
Hampton, Virginia, 23666, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507, United States
Virginia Oncology Associates
Virginia Beach, Virginia, 23456, United States
Swedish Medical Center First Hill, IDS Pharmacy
Seattle, Washington, 98104, United States
Seattle Children's IDS Pharmacy - Attn. Laura Winter
Seattle, Washington, 98105, United States
Seattle Children's
Seattle, Washington, 98105, United States
Lisa Nakatsu, RPh
Seattle, Washington, 98122, United States
Fox Valley Hematology & Oncology, SC
Appleton, Wisconsin, 59413, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Fox Valley Hematology & Oncology, SC
Oshkosh, Wisconsin, 59404, United States
Aurora Health Care, Aurora Cancer Care
Wauwatosa, Wisconsin, 53226, United States
Aurora Health Care, Aurora Cancer Care
West Allis, Wisconsin, 53227, United States
Related Publications (1)
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.
PMID: 32432489DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2014
First Posted
December 9, 2014
Last Updated
August 20, 2019
Record last verified: 2019-08