search
Back to results

Comparison of Three Treatment Regimens in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
sargramostim
cyclophosphamide
cytarabine
gemtuzumab ozogamicin
liposomal daunorubicin citrate
topotecan hydrochloride
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute myeloid leukemia, adult acute erythroid leukemia (M6), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute promyelocytic leukemia (M3), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute megakaryoblastic leukemia (M7), adult acute monocytic leukemia (M5b), adult acute minimally differentiated myeloid leukemia (M0)

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven acute myelogenous leukemia of one of the following types: Acute myeloblastic leukemia (FAB type M0, M1, or M2) Acute promyelocytic leukemia (FAB type M3) allowed if ineligible for an ECOG M3 protocol or if no tretinoin or arsenic trioxide therapy is planned Acute myelomonocytic leukemia (FAB type M4) Acute monocytic leukemia (FAB type M5) Acute erythroleukemia (FAB type M6) Acute megakaryocytic leukemia (FAB type M7) Must meet 1 of the following criteria: Relapse less than 6 months after first complete remission (CR) Relapse 6-12 months after first CR Refractory to conventional initial induction chemotherapy (no more than 2 courses) or first reinduction (no more than 1 course) Must have marrow documentation of residual leukemia after chemotherapy (for at least 2 weeks duration) Second or greater relapse No relapse greater than 1 year after achieving first CR Blast cells must be CD33 positive Prior CNS leukemia allowed if there is currently documentation of no CNS involvement on CSF examination (i.e., negative CSF by lumbar puncture) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.0 mg/dL* SGOT less than 2 times upper limit of normal* NOTE: *Unless due to leukemia infiltration Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: See Chemotherapy No myocardial infarction within the past 3 months No significant congestive heart failure No significant cardiac arrhythmia Cardiac ejection fraction normal by MUGA scan or echocardiogram Resting ejection fraction at least 50% or at least 5% increase with exercise Shortening fraction at least 24% or normal by echocardiogram Other: Not pregnant or nursing Fertile patients must use effective contraception No concurrent organ damage or other medical problems that would precludestudy therapy No concurrent evidence (including positive blood or deep tissue cultures or stains) of invasive fungal infection No hypersensitivity to ingredients of gemtuzumab ozogamicin or daunorubicin liposomal No other active tumor that would interfere with study therapy or increase risk PRIOR CONCURRENT THERAPY: Biologic therapy: No prior gemtuzumab ozogamicin Chemotherapy: See Disease Characteristics See Biologic therapy No prior daunorubicin liposomal or topotecan Prior doxorubicin (no greater than 300 mg/m2), daunorubicin (no greater than 300 mg/m2), idarubicin (no greater than 100 mg/m2), or mitoxantrone (no greater than 100 mg/m2) allowed if left ventricular function is adequate At least 4 weeks since prior chemotherapy except patients who are refractory to conventional initial induction chemotherapy Prior hydroxyurea allowed within 4 weeks prior to beginning study Hydroxyurea must be discontinued at least 24 hours prior to beginning study Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy except patients who are refractory to conventional initial induction chemotherapy Surgery: Not specified

Sites / Locations

  • CCOP - Scottsdale Oncology Program
  • Cancer Center and Beckman Research Institute, City of Hope
  • Veterans Affairs Medical Center - Palo Alto
  • Stanford University Medical Center
  • CCOP - Colorado Cancer Research Program, Inc.
  • CCOP - Christiana Care Health Services
  • Veterans Affairs Medical Center - Gainsville
  • Veterans Affairs Medical Center - Miami
  • H. Lee Moffitt Cancer Center and Research Institute
  • Veterans Affairs Medical Center - Tampa (Haley)
  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
  • Veterans Affairs Medical Center - Lakeside Chicago
  • CCOP - Central Illinois
  • CCOP - Evanston
  • CCOP - Illinois Oncology Research Association
  • CCOP - Carle Cancer Center
  • Indiana University Cancer Center
  • Veterans Affairs Medical Center - Indianapolis (Roudebush)
  • CCOP - Cedar Rapids Oncology Project
  • CCOP - Iowa Oncology Research Association
  • Holden Comprehensive Cancer Center at The University of Iowa
  • MBCCOP - LSU Health Sciences Center
  • CCOP - Ochsner
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • New England Medical Center Hospital
  • Beth Israel Deaconess Medical Center
  • CCOP - Ann Arbor Regional
  • CCOP - Kalamazoo
  • CCOP - Duluth
  • Veterans Affairs Medical Center - Minneapolis
  • University of Minnesota Cancer Center
  • Mayo Clinic Cancer Center
  • CCOP - Metro-Minnesota
  • Veterans Affairs Medical Center - Omaha
  • CCOP - Missouri Valley Cancer Consortium
  • CCOP - Southern Nevada Cancer Research Foundation
  • Veterans Affairs Medical Center - East Orange
  • CCOP - Northern New Jersey
  • Cancer Institute of New Jersey
  • Albert Einstein Comprehensive Cancer Center
  • MBCCOP-Our Lady of Mercy Cancer Center
  • Veterans Affairs Medical Center - Brooklyn
  • Veterans Affairs Medical Center - New York
  • NYU School of Medicine's Kaplan Comprehensive Cancer Center
  • University of Rochester Cancer Center
  • CCOP - Merit Care Hospital
  • Ireland Cancer Center
  • Cleveland Clinic Taussig Cancer Center
  • CCOP - Columbus
  • CCOP - Toledo Community Hospital Oncology Program
  • CCOP - Oklahoma
  • Hahnemann University Hospital
  • University of Pennsylvania Cancer Center
  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
  • Fox Chase Cancer Center
  • University of Pittsburgh Cancer Institute
  • Veterans Affairs Medical Center - Pittsburgh
  • CCOP - MainLine Health
  • CCOP - Sioux Community Cancer Consortium
  • Veterans Affairs Medical Center - Madison
  • University of Wisconsin Comprehensive Cancer Center
  • CCOP - Marshfield Medical Research and Education Foundation
  • MBCCOP - San Juan
  • Veterans Affairs Medical Center - San Juan
  • Pretoria Academic Hospitals

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
June 20, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00005962
Brief Title
Comparison of Three Treatment Regimens in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia
Official Title
A Phase II Randomized Trial of Immunologic and Chemotherapeutic Agents for Treatment of Patients With Relapsed or Refractory Acute Myelogenous Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 4, 2000 (Actual)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. 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. Combining more than one drug or combining monoclonal antibody with chemotherapy may kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia. PURPOSE: Randomized phase II trial to compare the effectiveness of three treatment regimens in treating patients who have relapsed or refractory acute myelogenous leukemia.
Detailed Description
OBJECTIVES: Compare the rates of complete response (CR) and CR without full platelet recovery in patients with relapsed or refractory acute myelogenous leukemia treated with gemtuzumab ozogamicin and cytarabine vs daunorubicin liposomal and cytarabine vs cyclophosphamide, cytarabine, and topotecan. Compare the toxicities of these 3 regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified by disease status (relapse less than 6 months after first complete response (CR) vs relapse 6-12 months after first CR vs refractory to conventional initial induction chemotherapy (no more than 2 courses) or first reinduction (no more than 1 course) vs second or greater relapse). Induction: Patients are randomized to 1 of 3 treatment arms: Arm I: Patients receive cytarabine IV over 2 hours on days 1-4 and gemtuzumab ozogamicin IV over 2 hours on day 5. Arm II: Patients receive daunorubicin liposomal IV over a minimum of 2 hours on days 1-3 and cytarabine IV over 2 hours (beginning immediately after completion of daunorubicin liposomal infusion) on days 1-4. Arm III: Patients receive cyclophosphamide IV over 1 hour every 12 hours on days 1-3, cytarabine IV over 2 hours (beginning immediately after completion of cyclophosphamide infusion) on days 2-6, and topotecan IV continuously on days 2-6. Consolidation: Patients who achieve complete remission (CR) receive 1 additional course of induction therapy on the same arm to which they were originally randomized beginning within 4-6 weeks after initial documentation of CR. Patients on arm II receive no additional daunorubicin liposomal if resting ejection fraction is less than 50% preconsolidation. All patients receive sargramostim (GM-CSF) IV over 4 hours or SQ daily beginning 24 hours after completion of consolidation therapy and continuing until blood counts recover. Patients are followed every 3 months through year 2, every 6 months through year 5, and then annually thereafter until death. PROJECTED ACCRUAL: A maximum of 150-165 patients (50-55 per arm) will be accrued for this study within 2 years.

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, adult acute erythroid leukemia (M6), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute promyelocytic leukemia (M3), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute megakaryoblastic leukemia (M7), adult acute monocytic leukemia (M5b), adult acute minimally differentiated myeloid leukemia (M0)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Type
Drug
Intervention Name(s)
gemtuzumab ozogamicin
Intervention Type
Drug
Intervention Name(s)
liposomal daunorubicin citrate
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven acute myelogenous leukemia of one of the following types: Acute myeloblastic leukemia (FAB type M0, M1, or M2) Acute promyelocytic leukemia (FAB type M3) allowed if ineligible for an ECOG M3 protocol or if no tretinoin or arsenic trioxide therapy is planned Acute myelomonocytic leukemia (FAB type M4) Acute monocytic leukemia (FAB type M5) Acute erythroleukemia (FAB type M6) Acute megakaryocytic leukemia (FAB type M7) Must meet 1 of the following criteria: Relapse less than 6 months after first complete remission (CR) Relapse 6-12 months after first CR Refractory to conventional initial induction chemotherapy (no more than 2 courses) or first reinduction (no more than 1 course) Must have marrow documentation of residual leukemia after chemotherapy (for at least 2 weeks duration) Second or greater relapse No relapse greater than 1 year after achieving first CR Blast cells must be CD33 positive Prior CNS leukemia allowed if there is currently documentation of no CNS involvement on CSF examination (i.e., negative CSF by lumbar puncture) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.0 mg/dL* SGOT less than 2 times upper limit of normal* NOTE: *Unless due to leukemia infiltration Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: See Chemotherapy No myocardial infarction within the past 3 months No significant congestive heart failure No significant cardiac arrhythmia Cardiac ejection fraction normal by MUGA scan or echocardiogram Resting ejection fraction at least 50% or at least 5% increase with exercise Shortening fraction at least 24% or normal by echocardiogram Other: Not pregnant or nursing Fertile patients must use effective contraception No concurrent organ damage or other medical problems that would precludestudy therapy No concurrent evidence (including positive blood or deep tissue cultures or stains) of invasive fungal infection No hypersensitivity to ingredients of gemtuzumab ozogamicin or daunorubicin liposomal No other active tumor that would interfere with study therapy or increase risk PRIOR CONCURRENT THERAPY: Biologic therapy: No prior gemtuzumab ozogamicin Chemotherapy: See Disease Characteristics See Biologic therapy No prior daunorubicin liposomal or topotecan Prior doxorubicin (no greater than 300 mg/m2), daunorubicin (no greater than 300 mg/m2), idarubicin (no greater than 100 mg/m2), or mitoxantrone (no greater than 100 mg/m2) allowed if left ventricular function is adequate At least 4 weeks since prior chemotherapy except patients who are refractory to conventional initial induction chemotherapy Prior hydroxyurea allowed within 4 weeks prior to beginning study Hydroxyurea must be discontinued at least 24 hours prior to beginning study Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy except patients who are refractory to conventional initial induction chemotherapy Surgery: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark R. Litzow, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Scottsdale Oncology Program
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5404
Country
United States
Facility Name
Cancer Center and Beckman Research Institute, City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Veterans Affairs Medical Center - Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5408
Country
United States
Facility Name
CCOP - Colorado Cancer Research Program, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209-5031
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Veterans Affairs Medical Center - Gainsville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608-1197
Country
United States
Facility Name
Veterans Affairs Medical Center - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Veterans Affairs Medical Center - Tampa (Haley)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Veterans Affairs Medical Center - Lakeside Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
CCOP - Evanston
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Veterans Affairs Medical Center - Indianapolis (Roudebush)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403-1206
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1016
Country
United States
Facility Name
Holden Comprehensive Cancer Center at The University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
MBCCOP - LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
CCOP - Ochsner
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
New England Medical Center Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
CCOP - Ann Arbor Regional
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
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
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Veterans Affairs Medical Center - Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
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 - East Orange
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018-1095
Country
United States
Facility Name
CCOP - Northern New Jersey
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Albert Einstein Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
MBCCOP-Our Lady of Mercy Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
Veterans Affairs Medical Center - Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11209
Country
United States
Facility Name
Veterans Affairs Medical Center - New York
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of Rochester Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
CCOP - Merit Care Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43206
Country
United States
Facility Name
CCOP - Toledo Community Hospital Oncology Program
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623-3456
Country
United States
Facility Name
CCOP - Oklahoma
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Hahnemann University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102-1192
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-3489
Country
United States
Facility Name
Veterans Affairs Medical Center - Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
CCOP - MainLine Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Veterans Affairs Medical Center - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
CCOP - Marshfield Medical Research and Education Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
MBCCOP - San Juan
City
San Juan
ZIP/Postal Code
00927-5800
Country
Puerto Rico
Facility Name
Veterans Affairs Medical Center - San Juan
City
San Juan
ZIP/Postal Code
00927-5800
Country
Puerto Rico
Facility Name
Pretoria Academic Hospitals
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
19804455
Citation
Litzow MR, Othus M, Cripe LD, Gore SD, Lazarus HM, Lee SJ, Bennett JM, Paietta EM, Dewald GW, Rowe JM, Tallman MS; Eastern Cooperative Oncology Group Leukemia Committee. Failure of three novel regimens to improve outcome for patients with relapsed or refractory acute myeloid leukaemia: a report from the Eastern Cooperative Oncology Group. Br J Haematol. 2010 Jan;148(2):217-25. doi: 10.1111/j.1365-2141.2009.07917.x. Epub 2009 Oct 5.
Results Reference
result
Citation
Litzow MR, Goloubeva O, Rowe J, et al.: A randomized phase II trial of gemtuzumab ozogamicin vs. liposomal daunorubicin vs. cyclophosphamide plus topotecan, each combined with intermediate dose Ara-C for the treatment of patients with relapsed or refractory acute myelogenous leukemia . [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2359, 2003.
Results Reference
result

Learn more about this trial

Comparison of Three Treatment Regimens in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia

We'll reach out to this number within 24 hrs