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

Primary Purpose

CD33 Positive Acute Myelogenous Leukemia

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Antibody Drug Conjugate Chemotherapeutic
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for CD33 Positive Acute Myelogenous Leukemia focused on measuring Relapsed CD33 AML, Refractory CD33 AML, Relapsed CD33 APL, Refractory CD33 APL, Relapsed CD33 MDS, Refractory CD33 MDS

Eligibility Criteria

3 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. 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

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.

Sites / Locations

  • University of Alabama at Birmingham/Children's of Alabama
  • Alaska Oncology & Hematology, LLC
  • Providence Alaska Medical Center
  • Providence Cancer Center
  • Banner Pediatric Specialists Hematology/Oncology Clinic
  • Cardon Children's Medical Center.
  • Phoenix Children's Hospital
  • Children's Hospital Of Los Angeles - University Of Southern California School Of Medicine
  • Kaiser Permanente - Oakland Medical Center
  • Kaiser Permanente - Oakland
  • Children's Hospital of Orange County
  • Kaiser Permanente - Roseville
  • UCSD/ Rady Children's Hospital
  • Kaiser Permanente - Santa Clara
  • c/o Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven
  • Smilow Cancer Hospital at Yale-New Haven
  • Yale New-Haven Hospital & Smilow Cancer Center
  • Yale University
  • Yale Medical Group
  • Nemours - A.I. duPont Hospital for Children
  • Children's National Medical Center
  • JDCH pediatric Oncology and Hematology
  • Joe Dimaggio Children's Hospital
  • Memorial Regional Hospital
  • Nemours Children's Clinic
  • Baptist Medical Center/Wolfson Children's Hospital
  • Blood and Marrow Transplant Center
  • Cancer Institute of Florida
  • Florida Hospital Cancer Institute
  • Nemours Children's Hospital
  • Memorial Cancer Institute at Memorial Hospital West
  • Memorial Hospital West
  • Johns Hopkins All Children's Hospital IDS Pharmacy
  • Johns Hopkins All Children's Hospital
  • Johns Hopkins All Children's Outpatient Care Pediatric Hematology/Oncology Department
  • H.Lee Moffitt Cancer Center and Research Institute
  • Children's Healthcare of Atlanta at Egleston
  • The Blood & Marrow Transplant Group Of Georgia
  • Children's Healthcare of Atlanta at Scottish Rite
  • Northside Hospital
  • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Investigational Drugs Service Pharmacy, Attn. Judy Pi, PharmD, Ami Patel, PharmD
  • The University of Chicago Medical Center
  • The University of Chicago
  • University of Chicago Medical Center
  • Cardinal Bernardin Cancer Center/Loyola University Medical Center
  • Loyola University Chicago, performing research at Loyola University Medical Center
  • Loyola University Medical Center
  • Indiana University Riley Hospital for Children
  • IU Health Pharmacy
  • Indiana Blood and Marrow Transplantation - Administrative Offices
  • Indiana Blood and Marrow Transplantation
  • St.Francis Hospital
  • University of Kansas Hospital
  • The University of Kansas Cancer Center and Medical Pavilion
  • The University of Kansas Cancer Center and Medical Pavillion
  • University of Kansas Cancer Center
  • UK Healthcare Markey Cancer Center
  • Johns Hopkins University IDS Pharmacy
  • Johns Hopkins University
  • Massachusetts General Hospital
  • Mayo Clinic
  • The West Clinic, P.C. dba West Cancer Center
  • Siteman Cancer Center - West County
  • Children's Mercy Hospital
  • Barnes-Jewish Hospital
  • Washington University Infusion Center Pharmacy
  • Washington University School of Medicine, Siteman Cancer Center
  • Washington University School of Medicine
  • Siteman Cancer Center - South County
  • Robert Wood Johnson University Hospital
  • Rutgers Cancer Institute of New Jersey
  • Roswell Park Cancer Institute
  • North Shore Hematology Oncology Associates, P.C.
  • Weill Cornell Medical College - New York-Presbyterian Hospital
  • Memorial Sloan-Kettering Cancer Center
  • Weill Cornell Medical College - New York-Presbyterian Hospital
  • University of Rochester Cancer Center Pharmacy
  • University of Rochester Medical Center
  • Brody School of Medicine at ECU
  • Vidant Medical Center
  • University Hospitals of Cleveland Rainbow Babies & Children's Hospital
  • Nationwide Children's Hospital
  • Geisinger Medical Center
  • Milton Hershey Medical Center
  • The Children's Hospital of Philadelphia
  • Thomas Jefferson University (Tju) - Jefferson University Physicians (Jup)
  • Thomas Jefferson University, Investigative Drug Service
  • Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office (Clinical)
  • Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office (Regulatory)
  • Thomas Jefferson University
  • St. Christopher's Hospital for Children
  • Allegheny Health Network, Cancer Institute, West Penn Hospital
  • The West Clinic, P.C. dba West Cancer Center
  • East Tennessee Children's Hospital
  • St. Jude Children's Research Hospital
  • Baptist Memorial Hospital
  • The West Clinic, P.C. dba West Cancer Center
  • Sarah Cannon Research Institute
  • Sarah Cannon Center for Blood Cancer
  • Sarah Cannon Research Institute
  • Tennessee Oncology - Nashville
  • Tennessee Oncology, PLLC
  • The Children's Hospital at TriStar Centennial
  • TriStar Centennial Medical Center/Sarah Cannon Cener for Blood Cancer
  • TriStar Centennial Medical Center
  • TriStar Medical Group Children's Specialist
  • VA Tennessee Valley Healthcare System - Nashville Campus
  • Monroe Carell Jr. Children's Hospital at Vanderbilt
  • Vanderbilt University Medical Center - The Vanderbilt Clinic
  • Children's Blood and Cancer Center
  • Dell Children's Medical Center of Central Texas
  • Dell Children's Medical Center
  • El Paso Children's Hospital
  • Texas Tech University Health Sciences Center
  • Cook Children's Hematology/Oncology Center
  • Cook Children's Medical Center
  • Cook Children's Hematology/Oncology Center - Grapevine
  • Houston Methodist Hospital
  • Texas Children's Hospital Attn: Investigational Pharmacy Services
  • Texas Children's Hospital
  • Houston Methodist Cancer Center
  • Huntsman Cancer Hospital
  • Huntsman Cancer Institute-University of Utah
  • Primary Children's Hospital
  • Cancer Center IDS Pharmacy Attn: Lauren Benusa, Pharm D.
  • Emily Couric Clinical Cancer Center
  • UVA Health System
  • Virginia Oncology Associates
  • Children's Hospital of the King's Daughters
  • Virginia Oncology Associates
  • Swedish Medical Center First Hill, IDS Pharmacy
  • Seattle Children's IDS Pharmacy - Attn. Laura Winter
  • Seattle Children's
  • Lisa Nakatsu, RPh
  • Fox Valley Hematology & Oncology, SC
  • Aurora BayCare Medical Center
  • Children's Hospital of Wisconsin
  • Medical College of Wisconsin
  • Fox Valley Hematology & Oncology, SC
  • Aurora Health Care, Aurora Cancer Care
  • Aurora Health Care, Aurora Cancer Care

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 4, 2014
Last Updated
August 17, 2019
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02312037
Brief Title
Expanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients In The USA Without Access To Comparable Or Alternative Therapy
Acronym
AML
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
Study Type
Expanded Access

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CD33 Positive Acute Myelogenous Leukemia
Keywords
Relapsed CD33 AML, Refractory CD33 AML, Relapsed CD33 APL, Refractory CD33 APL, Relapsed CD33 MDS, Refractory CD33 MDS

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Antibody Drug Conjugate Chemotherapeutic
Other Intervention Name(s)
Gemtuzumab ozogamicin
Intervention Description
Three Treatment Regimens: Mylotarg <=9 mg/m2 as a single agent on Day 1 & 14 of a 28-day cycle for a total of two cycles Mylotarg in combination with a recognized anthracycline and/or nucleoside-antagonist containing regimen Mylotarg as monotherapy or in tested combinations with ATRA and/or arsenic trioxide for APL

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham/Children's of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Alaska Oncology & Hematology, LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508-2980
Country
United States
Facility Name
Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Providence Cancer Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Banner Pediatric Specialists Hematology/Oncology Clinic
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Cardon Children's Medical Center.
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Children's Hospital Of Los Angeles - University Of Southern California School Of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Kaiser Permanente - Oakland Medical Center
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Kaiser Permanente - Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Kaiser Permanente - Roseville
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
UCSD/ Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Kaiser Permanente - Santa Clara
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
c/o Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Smilow Cancer Hospital at Yale-New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale New-Haven Hospital & Smilow Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Yale Medical Group
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Nemours - A.I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
JDCH pediatric Oncology and Hematology
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Joe Dimaggio Children's Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207-8426
Country
United States
Facility Name
Baptist Medical Center/Wolfson Children's Hospital
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Blood and Marrow Transplant Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Cancer Institute of Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Nemours Children's Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Facility Name
Memorial Cancer Institute at Memorial Hospital West
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Memorial Hospital West
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Johns Hopkins All Children's Hospital IDS Pharmacy
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Johns Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Johns Hopkins All Children's Outpatient Care Pediatric Hematology/Oncology Department
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
H.Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Children's Healthcare of Atlanta at Egleston
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
The Blood & Marrow Transplant Group Of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-4790
Country
United States
Facility Name
Children's Healthcare of Atlanta at Scottish Rite
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Investigational Drugs Service Pharmacy, Attn. Judy Pi, PharmD, Ami Patel, PharmD
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Cardinal Bernardin Cancer Center/Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Loyola University Chicago, performing research at Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Indiana University Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5225
Country
United States
Facility Name
IU Health Pharmacy
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indiana Blood and Marrow Transplantation - Administrative Offices
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Indiana Blood and Marrow Transplantation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
St.Francis Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
The University of Kansas Cancer Center and Medical Pavilion
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
The University of Kansas Cancer Center and Medical Pavillion
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
UK Healthcare Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Johns Hopkins University IDS Pharmacy
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
The West Clinic, P.C. dba West Cancer Center
City
Southaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Facility Name
Siteman Cancer Center - West County
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University Infusion Center Pharmacy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine, Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Siteman Cancer Center - South County
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63129
Country
United States
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
North Shore Hematology Oncology Associates, P.C.
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Weill Cornell Medical College - New York-Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medical College - New York-Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester Cancer Center Pharmacy
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Brody School of Medicine at ECU
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Vidant Medical Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
University Hospitals of Cleveland Rainbow Babies & Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Milton Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University (Tju) - Jefferson University Physicians (Jup)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-4215
Country
United States
Facility Name
Thomas Jefferson University, Investigative Drug Service
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office (Clinical)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office (Regulatory)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
St. Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
Allegheny Health Network, Cancer Institute, West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
The West Clinic, P.C. dba West Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
East Tennessee Children's Hospital
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
The West Clinic, P.C. dba West Cancer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
34203
Country
United States
Facility Name
Sarah Cannon Center for Blood Cancer
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Oncology - Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
The Children's Hospital at TriStar Centennial
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
TriStar Centennial Medical Center/Sarah Cannon Cener for Blood Cancer
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
TriStar Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
TriStar Medical Group Children's Specialist
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
VA Tennessee Valley Healthcare System - Nashville Campus
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Monroe Carell Jr. Children's Hospital at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Vanderbilt University Medical Center - The Vanderbilt Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Children's Blood and Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Name
Dell Children's Medical Center of Central Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Name
Dell Children's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Name
El Paso Children's Hospital
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Cook Children's Hematology/Oncology Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Cook Children's Hematology/Oncology Center - Grapevine
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Children's Hospital Attn: Investigational Pharmacy Services
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Methodist Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Huntsman Cancer Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Huntsman Cancer Institute-University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Cancer Center IDS Pharmacy Attn: Lauren Benusa, Pharm D.
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Emily Couric Clinical Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
UVA Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Virginia Oncology Associates
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Children's Hospital of the King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Virginia Oncology Associates
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Facility Name
Swedish Medical Center First Hill, IDS Pharmacy
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Seattle Children's IDS Pharmacy - Attn. Laura Winter
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Seattle Children's
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Lisa Nakatsu, RPh
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Fox Valley Hematology & Oncology, SC
City
Appleton
State/Province
Wisconsin
ZIP/Postal Code
59413
Country
United States
Facility Name
Aurora BayCare Medical Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311
Country
United States
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Fox Valley Hematology & Oncology, SC
City
Oshkosh
State/Province
Wisconsin
ZIP/Postal Code
59404
Country
United States
Facility Name
Aurora Health Care, Aurora Cancer Care
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Aurora Health Care, Aurora Cancer Care
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32432489
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1761026&StudyName=Expanded%20Access%20/Compassionate%20Use%20Protocol%20For%20Relapsed%20Or%20Refractory%20CD33%20Positive%20AML%20Patients%20In%20The%20USA%20Without%20Access%20To%20Comparabl
Description
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Learn more about this trial

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

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