Expanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients In The USA Without Access To Comparable Or Alternative Therapy
- Conditions
- CD33 Positive Acute Myelogenous Leukemia
- Registration Number
- NCT02312037
- Lead Sponsor
- Pfizer
- 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
- Detailed Description
Contact:
B1761026@iconplc.com
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- 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
-
Age >=3 months
-
Adequate non-hematologic organ function
-
- 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.
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (135)
Kaiser Permanente - Santa Clara
🇺🇸Santa Clara, California, United States
Kaiser Permanente - Oakland Medical Center
🇺🇸Oakland, California, United States
Kaiser Permanente - Roseville
🇺🇸Roseville, California, United States
Kaiser Permanente - Oakland
🇺🇸Oakland, California, United States
Vidant Medical Center
🇺🇸Greenville, North Carolina, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Johns Hopkins All Children's Hospital IDS Pharmacy
🇺🇸Saint Petersburg, Florida, United States
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
Washington University School of Medicine, Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
Cardon Children's Medical Center.
🇺🇸Mesa, Arizona, United States
Providence Cancer Center
🇺🇸Anchorage, Alaska, United States
JDCH pediatric Oncology and Hematology
🇺🇸Hollywood, Florida, United States
Nemours - A.I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Banner Pediatric Specialists Hematology/Oncology Clinic
🇺🇸Mesa, Arizona, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Loyola University Chicago, performing research at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Alaska Oncology & Hematology, LLC
🇺🇸Anchorage, Alaska, United States
Johns Hopkins All Children's Outpatient Care Pediatric Hematology/Oncology Department
🇺🇸Saint Petersburg, Florida, United States
Yale Medical Group
🇺🇸Trumbull, Connecticut, United States
Memorial Hospital West
🇺🇸Pembroke Pines, Florida, United States
University of Kansas Hospital
🇺🇸Kansas City, Kansas, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
Memorial Cancer Institute at Memorial Hospital West
🇺🇸Pembroke Pines, Florida, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office (Clinical)
🇺🇸Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Weill Cornell Medical College - New York-Presbyterian Hospital
🇺🇸New York, New York, United States
Johns Hopkins All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States
University of Kansas Cancer Center
🇺🇸Westwood, Kansas, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States
The West Clinic, P.C. dba West Cancer Center
🇺🇸Memphis, Tennessee, United States
University of Rochester Cancer Center Pharmacy
🇺🇸Rochester, New York, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Dell Children's Medical Center
🇺🇸Austin, Texas, United States
Aurora BayCare Medical Center
🇺🇸Green Bay, Wisconsin, United States
North Shore Hematology Oncology Associates, P.C.
🇺🇸East Setauket, New York, United States
Thomas Jefferson University (Tju) - Jefferson University Physicians (Jup)
🇺🇸Philadelphia, Pennsylvania, United States
East Tennessee Children's Hospital
🇺🇸Knoxville, Tennessee, United States
The Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Investigative Drug Service
🇺🇸Philadelphia, Pennsylvania, United States
Baptist Memorial Hospital
🇺🇸Memphis, Tennessee, United States
Children's Blood and Cancer Center
🇺🇸Austin, Texas, United States
Texas Tech University Health Sciences Center
🇺🇸El Paso, Texas, United States
Cook Children's Hematology/Oncology Center - Grapevine
🇺🇸Grapevine, Texas, United States
Aurora Health Care, Aurora Cancer Care
🇺🇸West Allis, Wisconsin, United States
Seattle Children's IDS Pharmacy - Attn. Laura Winter
🇺🇸Seattle, Washington, United States
Seattle Children's
🇺🇸Seattle, Washington, United States
Johns Hopkins University IDS Pharmacy
🇺🇸Baltimore, Maryland, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Children's Hospital Of Los Angeles - University Of Southern California School Of Medicine
🇺🇸Los Angeles, California, United States
Children's Healthcare of Atlanta at Egleston
🇺🇸Atlanta, Georgia, United States
The Blood & Marrow Transplant Group Of Georgia
🇺🇸Atlanta, Georgia, United States
Children's Healthcare of Atlanta at Scottish Rite
🇺🇸Atlanta, Georgia, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Investigational Drugs Service Pharmacy, Attn. Judy Pi, PharmD, Ami Patel, PharmD
🇺🇸Chicago, Illinois, United States
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
The University of Chicago
🇺🇸Chicago, Illinois, United States
University Hospitals of Cleveland Rainbow Babies & Children's Hospital
🇺🇸Cleveland, Ohio, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Indiana University Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
IU Health Pharmacy
🇺🇸Indianapolis, Indiana, United States
St.Francis Hospital
🇺🇸Indianapolis, Indiana, United States
Indiana Blood and Marrow Transplantation - Administrative Offices
🇺🇸Indianapolis, Indiana, United States
Indiana Blood and Marrow Transplantation
🇺🇸Indianapolis, Indiana, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Texas Children's Hospital Attn: Investigational Pharmacy Services
🇺🇸Houston, Texas, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Houston Methodist Cancer Center
🇺🇸Houston, Texas, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Joe Dimaggio Children's Hospital
🇺🇸Hollywood, Florida, United States
Baptist Medical Center/Wolfson Children's Hospital
🇺🇸Jacksonville, Florida, United States
Cardinal Bernardin Cancer Center/Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
The University of Kansas Cancer Center and Medical Pavillion
🇺🇸Westwood, Kansas, United States
The University of Kansas Cancer Center and Medical Pavilion
🇺🇸Westwood, Kansas, United States
UK Healthcare Markey Cancer Center
🇺🇸Lexington, Kentucky, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Siteman Cancer Center - West County
🇺🇸Creve Coeur, Missouri, United States
Washington University Infusion Center Pharmacy
🇺🇸Saint Louis, Missouri, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Brody School of Medicine at ECU
🇺🇸Greenville, North Carolina, United States
Milton Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office (Regulatory)
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny Health Network, Cancer Institute, West Penn Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
El Paso Children's Hospital
🇺🇸El Paso, Texas, United States
Dell Children's Medical Center of Central Texas
🇺🇸Austin, Texas, United States
Cook Children's Hematology/Oncology Center
🇺🇸Fort Worth, Texas, United States
Cancer Center IDS Pharmacy Attn: Lauren Benusa, Pharm D.
🇺🇸Charlottesville, Virginia, United States
Emily Couric Clinical Cancer Center
🇺🇸Charlottesville, Virginia, United States
UVA Health System
🇺🇸Charlottesville, Virginia, United States
Virginia Oncology Associates
🇺🇸Virginia Beach, Virginia, United States
Children's Hospital of the King's Daughters
🇺🇸Norfolk, Virginia, United States
Swedish Medical Center First Hill, IDS Pharmacy
🇺🇸Seattle, Washington, United States
Lisa Nakatsu, RPh
🇺🇸Seattle, Washington, United States
Fox Valley Hematology & Oncology, SC
🇺🇸Oshkosh, Wisconsin, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Siteman Cancer Center - South County
🇺🇸Saint Louis, Missouri, United States
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
UCSD/ Rady Children's Hospital
🇺🇸San Diego, California, United States
University of Alabama at Birmingham/Children's of Alabama
🇺🇸Birmingham, Alabama, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Blood and Marrow Transplant Center
🇺🇸Orlando, Florida, United States
Cancer Institute of Florida
🇺🇸Orlando, Florida, United States
Nemours Children's Hospital
🇺🇸Orlando, Florida, United States
H.Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Sarah Cannon Center for Blood Cancer
🇺🇸Nashville, Tennessee, United States
Tennessee Oncology - Nashville
🇺🇸Nashville, Tennessee, United States
Tennessee Oncology, PLLC
🇺🇸Nashville, Tennessee, United States
The Children's Hospital at TriStar Centennial
🇺🇸Nashville, Tennessee, United States
TriStar Centennial Medical Center/Sarah Cannon Cener for Blood Cancer
🇺🇸Nashville, Tennessee, United States
TriStar Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
TriStar Medical Group Children's Specialist
🇺🇸Nashville, Tennessee, United States
VA Tennessee Valley Healthcare System - Nashville Campus
🇺🇸Nashville, Tennessee, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center - The Vanderbilt Clinic
🇺🇸Nashville, Tennessee, United States
Huntsman Cancer Hospital
🇺🇸Salt Lake City, Utah, United States
Huntsman Cancer Institute-University of Utah
🇺🇸Salt Lake City, Utah, United States
Primary Children's Hospital
🇺🇸Salt Lake City, Utah, United States
Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
c/o Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven
🇺🇸New Haven, Connecticut, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Smilow Cancer Hospital at Yale-New Haven
🇺🇸New Haven, Connecticut, United States
Yale New-Haven Hospital & Smilow Cancer Center
🇺🇸New Haven, Connecticut, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States