Back to resultsGemtuzumab Ozogamicin and High-Dose Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Primary Purpose
Leukemia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ara-C
gemtuzumab ozogamicin
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute myeloid leukemia
Eligibility Criteria
DISEASE CHARACTERISTICS: One of the following diagnoses: Primary refractory acute myeloid leukemia (AML) More than 10% blasts in the bone marrow or blood after recovery from 2 courses of standard cytarabine- and anthracycline-based induction chemotherapy No prior remission Relapsed AML More than 10% blasts in the bone marrow or blood after documented remission Prior remission lasted more than 30 days No prior treatment for current relapse CD33 expression on at least 20% of leukemia blast cells at initial diagnosis for primary refractory patients or at the time of relapse for all other patients No active CNS involvement PATIENT CHARACTERISTICS: Age: 17 and over Performance status: 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics WBC less than 30,000/mm^3 Hepatic: Bilirubin less than 2.0 mg/dL No veno-occlusive disease of the liver No chronic liver disease unless due to AML Renal: Not specified Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active serious infection PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since prior stem cell transplantation Chemotherapy: See Disease Characteristics Prior etoposide and/or thioguanine during remission induction allowed Prior hydroxyurea for control of AML allowed At least 24 hours since prior hydroxyurea At least 3 months since prior high-dose cytarabine (greater than 2 g/m^2/dose)-containing regimen No other concurrent chemotherapy Endocrine therapy: Concurrent steroids for adrenal failure, hypersensitivity reactions, or septic shock allowed Concurrent ophthalmic corticosteroids allowed Concurrent hormones for nondisease-related conditions (e.g., insulin for diabetes or estrogens or progestins for gynecologic conditions) allowed Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: More than 2 months since prior cytotoxic therapy
Sites / Locations
- Northeast Alabama Regional Medical Center
- Veterans Affairs Medical Center - Birmingham
- Rebecca and John Moores UCSD Cancer Center
- Veterans Affairs Medical Center - San Diego
- UCSF Comprehensive Cancer Center
- Veterans Affairs Medical Center - San Francisco
- CCOP - Christiana Care Health Services
- Lombardi Cancer Center at Georgetown University Medical Center
- Walter Reed Army Medical Center
- Veterans Affairs Medical Center - Washington, DC
- Broward General Medical Center
- Memorial Regional Hospital Comprehensive Cancer Center
- CCOP - Mount Sinai Medical Center
- Florida Hospital Cancer Institute
- Palm Beach Cancer Institute
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- University of Chicago Cancer Research Center
- Louis A. Weiss Memorial Hospital
- CCOP - Illinois Oncology Research Association
- West Suburban Center for Cancer Care
- Saint Anthony Medical Center
- Fort Wayne Medical Oncology and Hematology, Incorporated
- Hematology Oncology Associates of the Quad Cities
- Holden Comprehensive Cancer Center at University of Iowa
- Baptist Hospital East - Louisville
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- University of Massachusetts Memorial Medical Center - University Campus
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
- Veterans Affairs Medical Center - Minneapolis
- University of Minnesota Cancer Center
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- CCOP - Kansas City
- Barnes-Jewish Hospital
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- CCOP - Southern Nevada Cancer Research Foundation
- Veterans Affairs Medical Center - Las Vegas
- New Hampshire Oncology-Hematology, PA - Hooksett
- Norris Cotton Cancer Center at Dartmouth Medical School
- Cooper University Hospital
- Veterans Affairs Medical Center - Buffalo
- Elmhurst Hospital Center
- Queens Cancer Center of Queens Hospital
- CCOP - North Shore University Hospital
- North Shore University Hospital
- Memorial Sloan-Kettering Cancer Center
- New York Weill Cornell Cancer Center at Cornell University
- Mount Sinai Medical Center, NY
- University Hospital at State University of New York - Upstate Medical University
- Veterans Affairs Medical Center - Syracuse
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- Veterans Affairs Medical Center - Asheville
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- NorthEast Oncology Associates
- Veterans Affairs Medical Center - Durham
- Duke Comprehensive Cancer Center
- Cape Fear Valley Health System
- Lenoir Memorial Hospital Cancer Center
- FirstHealth Moore Regional Hospital
- New Hanover Regional Medical Center
- CCOP - Southeast Cancer Control Consortium
- Comprehensive Cancer Center at Wake Forest University
- Arthur G. James Cancer Hospital - Ohio State University
- Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
- Lifespan: The Miriam Hospital
- University of Tennessee Cancer Institute
- Veterans Affairs Medical Center - Memphis
- Veterans Affairs Medical Center - Dallas
- Green Mountain Oncology Group
- Vermont Cancer Center at University of Vermont
- Veterans Affairs Medical Center - White River Junction
- Martha Jefferson Hospital
- Virginia Oncology Associates - Norfolk
- MBCCOP - Massey Cancer Center
- Oncology and Hematology Associates of Southwest Virginia, Inc.
- St. Mary's Medical Center
- University of Puerto Rico School of Medicine Medical Sciences Campus
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort I
Cohort II
Cohort IA
Cohort IV
Arm Description
Immunotherapy with gemtuzumab
Gemtuzumab + ara-C
Gemtuzumab + ara C
Gemtuzumab + ara-C
Outcomes
Primary Outcome Measures
Complete remission rate
Secondary Outcome Measures
Toxicity
Full Information
NCT ID
NCT00006265
First Posted
September 11, 2000
Last Updated
July 12, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00006265
Brief Title
Gemtuzumab Ozogamicin and High-Dose Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Official Title
A Dose Escalation And Phase II Study Of Gemtuzumab Ozogamicin (CMA-676; Mylotarg) With High-Dose Cytarabine For Patients With Refractory Or Relapsed Acute Myeloid Leukemia (AML)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
RATIONALE: Monoclonal antibodies, such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining gemtuzumab ozogamicin with cytarabine may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemtuzumab ozogamicin with high-dose cytarabine in treating patients who have relapsed or refractory acute myeloid leukemia.
Detailed Description
OBJECTIVES:
Determine the response rate in patients with relapsed or refractory acute myeloid leukemia treated with gemtuzumab ozogamicin (CMA-676) and high-dose cytarabine.
Determine the safety and toxicity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of gemtuzumab ozogamicin (CMA-676) (phase I closed to accrual effective 08/25/2003). Patients are stratified according to disease status (refractory vs relapsed).
Phase I (closed to accrual effective 08/25/2003): Patients are enrolled in one of four cohorts.
Cohort I (closed to accrual as of 10/1/02): Patients receive CMA-676 at the first dose level IV over 2 hours on days 1 and 8.
Cohort IA (open to accrual as of 10/15/02): Patients receive high-dose cytarabine (HD-ARA-C) IV over 3 hours on days 1-5 and CMA-676 IV over 2 hours on day 7.
Cohort II: Patients receive HD-ARA-C as in cohort IA and CMA-676 at the first dose level IV over 2 hours on days 7 and 14.
Cohort IV: Patients receive CMA-676 at the second dose level and HD-ARA-C as in cohort II.
Dose escalation stops if at least 3 of 9 patients experience dose-limiting toxicity.
Phase II: Patients receive HD-ARA-C IV over 3 hours on days 1-5 and CMA-676 IV over 2 hours on day 7 (one course).
Patients are followed at 1 month, monthly for 6 months, every 3 months for 2 years, and then annually for 10 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for phase I of the study and a total of 37 patients will be accrued for phase II of the study within 2 years. (Phase I closed to accrual effective 08/25/2003).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
recurrent adult acute myeloid leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort I
Arm Type
Experimental
Arm Description
Immunotherapy with gemtuzumab
Arm Title
Cohort II
Arm Type
Experimental
Arm Description
Gemtuzumab + ara-C
Arm Title
Cohort IA
Arm Type
Experimental
Arm Description
Gemtuzumab + ara C
Arm Title
Cohort IV
Arm Type
Experimental
Arm Description
Gemtuzumab + ara-C
Intervention Type
Drug
Intervention Name(s)
ara-C
Other Intervention Name(s)
Cytarabine
Intervention Description
3 g/sq m IV infusion over 3 hours Days 1-5
Intervention Type
Biological
Intervention Name(s)
gemtuzumab ozogamicin
Other Intervention Name(s)
Mylotarg
Intervention Description
9 mg/sq m IV infusion over 2 hrs D 1 (Cohort I); D 7 (Cohorts II, IA, & IV); & D 14 (Cohort IV) 4.5 mg/sq m IV infusion over 2 hrs D 8 (Cohort I) & D 14 (Cohort II)
Primary Outcome Measure Information:
Title
Complete remission rate
Time Frame
8 or 14 days after tx initiation & 30 d post tx
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
D 14, then 30, 60 , & 90 d post Tx, q 3 mon for 1 yr, then at relapse or death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
One of the following diagnoses:
Primary refractory acute myeloid leukemia (AML)
More than 10% blasts in the bone marrow or blood after recovery from 2 courses of standard cytarabine- and anthracycline-based induction chemotherapy
No prior remission
Relapsed AML
More than 10% blasts in the bone marrow or blood after documented remission
Prior remission lasted more than 30 days
No prior treatment for current relapse
CD33 expression on at least 20% of leukemia blast cells at initial diagnosis for primary refractory patients or at the time of relapse for all other patients
No active CNS involvement
PATIENT CHARACTERISTICS:
Age:
17 and over
Performance status:
0-2
Life expectancy:
Not specified
Hematopoietic:
See Disease Characteristics
WBC less than 30,000/mm^3
Hepatic:
Bilirubin less than 2.0 mg/dL
No veno-occlusive disease of the liver
No chronic liver disease unless due to AML
Renal:
Not specified
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active serious infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
At least 6 months since prior stem cell transplantation
Chemotherapy:
See Disease Characteristics
Prior etoposide and/or thioguanine during remission induction allowed
Prior hydroxyurea for control of AML allowed
At least 24 hours since prior hydroxyurea
At least 3 months since prior high-dose cytarabine (greater than 2 g/m^2/dose)-containing regimen
No other concurrent chemotherapy
Endocrine therapy:
Concurrent steroids for adrenal failure, hypersensitivity reactions, or septic shock allowed
Concurrent ophthalmic corticosteroids allowed
Concurrent hormones for nondisease-related conditions (e.g., insulin for diabetes or estrogens or progestins for gynecologic conditions) allowed
Radiotherapy:
No concurrent radiotherapy
Surgery:
Not specified
Other:
More than 2 months since prior cytotoxic therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Stone, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Northeast Alabama Regional Medical Center
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Veterans Affairs Medical Center - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233-1996
Country
United States
Facility Name
Rebecca and John Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
Veterans Affairs Medical Center - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Veterans Affairs Medical Center - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Lombardi Cancer Center at Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5000
Country
United States
Facility Name
Veterans Affairs Medical Center - Washington, DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Broward General Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Memorial Regional Hospital Comprehensive Cancer Center
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Palm Beach Cancer Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Veterans Affairs Medical Center - Chicago (Westside Hospital)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Louis A. Weiss Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
West Suburban Center for Cancer Care
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
Saint Anthony Medical Center
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61108
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology, Incorporated
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46885-5099
Country
United States
Facility Name
Hematology Oncology Associates of the Quad Cities
City
Bettendorf
State/Province
Iowa
ZIP/Postal Code
52722
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Baptist Hospital East - Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Veterans Affairs Medical Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Veterans Affairs Medical Center - Columbia (Truman Memorial)
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Ellis Fischel Cancer Center at University of Missouri - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Barnes-Jewish Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
CCOP - Southern Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Veterans Affairs Medical Center - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
New Hampshire Oncology-Hematology, PA - Hooksett
City
Hooksett
State/Province
New Hampshire
ZIP/Postal Code
03106
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth Medical School
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Veterans Affairs Medical Center - Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Elmhurst Hospital Center
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Facility Name
Queens Cancer Center of Queens Hospital
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
CCOP - North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York Weill Cornell Cancer Center at Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Medical Center, NY
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University Hospital at State University of New York - Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Veterans Affairs Medical Center - Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
City
Syracuse
State/Province
New York
ZIP/Postal Code
13217
Country
United States
Facility Name
Veterans Affairs Medical Center - Asheville
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28805
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
NorthEast Oncology Associates
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Veterans Affairs Medical Center - Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cape Fear Valley Health System
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28302-2000
Country
United States
Facility Name
Lenoir Memorial Hospital Cancer Center
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28503-1678
Country
United States
Facility Name
FirstHealth Moore Regional Hospital
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
New Hanover Regional Medical Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28402-9025
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104-4241
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Arthur G. James Cancer Hospital - Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Lifespan: The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
University of Tennessee Cancer Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Veterans Affairs Medical Center - Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Veterans Affairs Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Green Mountain Oncology Group
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Vermont Cancer Center at University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-3498
Country
United States
Facility Name
Veterans Affairs Medical Center - White River Junction
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009
Country
United States
Facility Name
Martha Jefferson Hospital
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
Virginia Oncology Associates - Norfolk
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
MBCCOP - Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Inc.
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
St. Mary's Medical Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
University of Puerto Rico School of Medicine Medical Sciences Campus
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
20688393
Citation
Stone RM, Moser B, Sanford B, Schulman P, Kolitz JE, Allen S, Stock W, Galinsky I, Vij R, Marcucci G, Hurd D, Larson RA; Cancer and Leukemia Group B. High dose cytarabine plus gemtuzumab ozogamicin for patients with relapsed or refractory acute myeloid leukemia: Cancer and Leukemia Group B study 19902. Leuk Res. 2011 Mar;35(3):329-33. doi: 10.1016/j.leukres.2010.07.017. Epub 2010 Aug 4.
Results Reference
result
Citation
Stone RM, Moser B, Schulman P, et al.: A dose escalation and phase II study of gemtuzumab ozogamicin (GO) with high-dose cytarabine (HiDAC) for patients (pts) with refractory or relapsed acute myeloid leukemia (AML): CALGB 19902. [Abstract] Blood 104 (11): A-873, 2004.
Results Reference
result
Learn more about this trial
Gemtuzumab Ozogamicin and High-Dose Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
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