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

Description

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

Study Start Date

Not specified

Estimated Completion Date

Not specified

Interventions

  • Biological: Antibody Drug Conjugate Chemotherapeutic

Specialties

  • Family Medicine: Complementary Medicine
  • Oncology: Leukemia/Lymphoma
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • Leukemia

Study ID

Pfizer -- B1761026

Status

Available

Trial ID

NCT02312037

Study Type

Expanded Access

Trial Phase

Phase 4

Enrollment Quota

Not Listed

Sponsor

Pfizer

Inclusion Criteria

  • 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.
  • 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

Exclusion Criteria

  • 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.

Gender

Both

Ages

3 Months and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (93)

Study Location Distance Name Phone Email
North Shore Hematology Oncology Associates PC - East Setauket, New York 21.2 miles None None None
North Shore Hematology Oncology Associates PC - East Setauket, New York 21.2 miles None None None
Rutgers Cancer Institute of New Jersey - New Brunswick, New Jersey 79.6 miles None None None
Rutgers Cancer Institute of New Jersey - New Brunswick, New Jersey 79.6 miles None None None
Robert Wood Johnson University Hospital - New Brunswick, New Jersey 80.6 miles None None None
Robert Wood Johnson University Hospital - New Brunswick, New Jersey 80.6 miles None None None
Thomas Jefferson University Sidney Kimmel Cancer Center Clinical Trials Office Clinical - Philadelphia, Pennsylvania 133.3 miles None None None
IP Shipment Thomas Jefferson University Investigative Drug Service - Philadelphia, Pennsylvania 133.3 miles None None None
Thomas Jefferson University Sidney Kimmel Cancer Center Clinical Trials Office Regulatory - Philadelphia, Pennsylvania 133.3 miles None None None
Thomas Jefferson University Sidney Kimmel Cancer Center Clinical Trials Office Regulatory - Philadelphia, Pennsylvania 133.3 miles None None None
Thomas Jefferson University - Philadelphia, Pennsylvania 133.3 miles None None None
IP PrepStorage Thomas Jefferson University Investigative Drug Service - Philadelphia, Pennsylvania 133.3 miles None None None
IP Shipment Thomas Jefferson University Investigative Drug Service - Philadelphia, Pennsylvania 133.3 miles None None None
IP PrepStorage Thomas Jefferson University Investigative Drug Service - Philadelphia, Pennsylvania 133.3 miles None None None
The Childrens Hospital of Philadelphia - Philadelphia, Pennsylvania 134.5 miles None None None
Nemours AI duPont Hospital for Children - Wilmington, Delaware 155.5 miles None None None
Nemours AI duPont Hospital for Children - Wilmington, Delaware 155.5 miles None None None
Geisinger Medical Center - Danville, Pennsylvania 176.4 miles None None None
Johns Hopkins University - Baltimore, Maryland 219.6 miles None None None
Johns Hopkins University - Baltimore, Maryland 219.6 miles None None None
Childrens National Medical Center - Washington, District of Columbia 255.3 miles None None None
Roswell Park Cancer Institute - Buffalo, New York 310.8 miles None None None
Roswell Park Cancer Institute - Buffalo, New York 310.8 miles None None None
Childrens Hospital of the Kings Daughters - Norfolk, Virginia 343.3 miles None None None
Childrens Hospital of the Kings Daughters - Norfolk, Virginia 343.3 miles None None None
Drug Shipment Address IDS Pharmacy - Charlottesville, Virginia 357.0 miles None None None
Drug Shipment Address IDS Pharmacy - Charlottesville, Virginia 357.0 miles None None None
UVA Health System - Charlottesville, Virginia 357.0 miles None None None
Emily Couric Clinical Cancer Center - Charlottesville, Virginia 357.1 miles None None None
University Hospitals of Cleveland - Cleveland, Ohio 434.6 miles None None None
University Hospitals of Cleveland - Cleveland, Ohio 434.6 miles None None None
Vidant Medical Center - Greenville, North Carolina 449.0 miles None None None
Brody School of Medicine at ECU - Greenville, North Carolina 449.0 miles None None None
Brody School of Medicine at ECU - Greenville, North Carolina 449.0 miles None None None
Indiana Blood and Marrow Transplantation - Indianapolis, Indiana 685.4 miles None None None
Indiana Blood and Marrow Transplantation Administrative Offices - Indianapolis, Indiana 685.4 miles None None None
Indiana Blood and Marrow Transplantation - Indianapolis, Indiana 685.4 miles None None None
Cardinal Bernardin Cancer CenterLoyola University Medical Center - Maywood, Illinois 757.2 miles None None None
Cardinal Bernardin Cancer CenterLoyola University Medical Center - Maywood, Illinois 757.2 miles None None None
Aurora Health Care Aurora Cancer Care - Wauwatosa, Wisconsin 769.3 miles None None None
Northside Hospital - Atlanta, Georgia 793.5 miles None None None
Childrens Healthcare of Atlanta at Scottish Rite - Atlanta, Georgia 793.5 miles None None None
Childrens Healthcare of Atlanta at Scottish Rite - Atlanta, Georgia 793.5 miles None None None
Childrens Healthcare of Atlanta at Egleston - Atlanta, Georgia 795.6 miles None None None
Childrens Healthcare of Atlanta at Egleston - Atlanta, Georgia 795.6 miles None None None
Fox Valley Hematology Oncology SC - Oshkosh, Wisconsin 805.7 miles None None None
Fox Valley Hematology Oncology SC - Oshkosh, Wisconsin 805.7 miles None None None
Washington University School of Medicine Siteman Cancer Center - Saint Louis, Missouri 919.8 miles None None None
Washington University Infusion Center Pharmacy - Saint Louis, Missouri 919.8 miles None None None
Washington University School of Medicine - Saint Louis, Missouri 919.8 miles None None None
BarnesJewish Hospital - Saint Louis, Missouri 919.8 miles None None None
Washington University School of Medicine Siteman Cancer Center - Saint Louis, Missouri 919.8 miles None None None
Siteman Cancer Center South County - Saint Louis, Missouri 926.8 miles None None None
Siteman Cancer Center South County - Saint Louis, Missouri 926.8 miles None None None
Siteman Cancer Center West County - Creve Coeur, Missouri 929.1 miles None None None
Florida Hospital Cancer Institute Drug Shipment Address - Orlando, Florida 989.4 miles None None None
Blood and Marrow Transplant Center - Orlando, Florida 989.4 miles None None None
The West Clinic PC - Memphis, Tennessee 996.2 miles None None None
Baptist Memorial Hospital - Memphis, Tennessee 996.2 miles None None None
The West Clinic PC - Memphis, Tennessee 996.2 miles None None None
The Jones Clinic PC - Germantown, Tennessee 999.8 miles None None None
St Jude Childrens Research Hospital Memphis - Memphis, Tennessee 1,003.6 miles None None None
The West Clinic PC - Southaven, Mississippi 1,007.8 miles None None None
Nationwide Childrens Hospital - Columbus, Ohio 1,016.8 miles None None None
Moffitt Cancer Center - Tampa, Florida 1,050.4 miles None None None
Moffitt Cancer Center - Tampa, Florida 1,050.4 miles None None None
University of Kansas Medical Center - Kansas City, Kansas 1,138.2 miles None None None
University Kansas Cancer Center - Westwood, Kansas 1,139.7 miles None None None
University Kansas Cancer Center - Westwood, Kansas 1,139.7 miles None None None
Cook Childrens HematologyOncology Center Grapevine - Grapevine, Texas 1,431.4 miles None None None
Cook Childrens HematologyOncology Center Grapevine - Grapevine, Texas 1,431.4 miles None None None
Cook Childrens Medical Center - Fort Worth, Texas 1,449.7 miles None None None
Cook Childrens HematologyOncology Center - Fort Worth, Texas 1,449.7 miles None None None
Cook Childrens Medical Center - Fort Worth, Texas 1,449.7 miles None None None
Texas Childrens Hospital - Houston, Texas 1,475.7 miles None None None
Texas Childrens Hospital Attn Investigational Pharmacy Services - Houston, Texas 1,475.7 miles None None None
Houston Methodist Hospital - Houston, Texas 1,475.7 miles None None None
Texas Childrens Hospital Attn Investigational Pharmacy Services - Houston, Texas 1,475.7 miles None None None
Texas Tech University Health Sciences Center - El Paso, Texas 1,946.0 miles None None None
Texas Tech University Health Sciences Center - El Paso, Texas 1,946.0 miles None None None
El Paso Childrens Hospital - El Paso, Texas 1,946.0 miles None None None
University of Utah Huntsman Cancer Institute - Salt Lake City, Utah 2,001.3 miles None None None
University of Utah Huntsman Cancer Institute - Salt Lake City, Utah 2,001.3 miles None None None
Huntsman Cancer Hospital - Salt Lake City, Utah 2,001.3 miles None None None
Cardon Childrens Medical Center - Mesa, Arizona 2,176.9 miles None None None
Banner Pediatric Specialists HematologyOncology Clinic - Mesa, Arizona 2,176.9 miles None None None
Cardon Childrens Medical Center - Mesa, Arizona 2,176.9 miles None None None
Seattle Childrens Hospital - Seattle, Washington 2,424.5 miles None None None
Investigational Product Shipment Location Lisa Nakatsu RPh Investigational Drug Service - Seattle, Washington 2,425.4 miles None None None
Investigational Product Shipment Location Lisa Nakatsu RPh Investigational Drug Service - Seattle, Washington 2,425.4 miles None None None
Minor and James Medical PLLC - Seattle, Washington 2,426.6 miles None None None
Swedish Cancer Institute - Seattle, Washington 2,426.6 miles None None None
Swedish Cancer Institute - Seattle, Washington 2,426.6 miles None None None

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