Back to resultsflt3L in Treating Patients With Acute Myeloid Leukemia
Primary Purpose
Leukemia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
recombinant flt3 ligand
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring adult acute myeloid leukemia in remission, 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
DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia in first, second, third, or subsequent complete remission (CR) Must be at least 60 years of age if first CR Must have had histological proof (from bone marrow aspirate, smears, or touch preps of marrow biopsy) of one of the following prior to achieving CR: Acute myeloblastic leukemia (M0, M1, M2) Acute promyelocytic leukemia (M3) Acute myelomonocytic leukemia (M4) Acute monocytic leukemia (M5) Acute erythroleukemia (M6) Acute megakaryocytic leukemia (M7) Refractory anemia with excess blasts in transformation PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3 times upper limit of normal (ULN) SGOT less than 3 times ULN Renal: Creatinine less than 2 mg/dL Cardiovascular: No clinically significant active cardiac disease Pulmonary: No clinically significant active pulmonary disease Other: Not pregnant or nursing Fertile patients must use effective contraception No uncontrolled or active autoimmune disease PRIOR CONCURRENT THERAPY: Biologic therapy: Prior autologous bone marrow transplantation (BMT) allowed No prior allogeneic BMT Other prior immunotherapy allowed if not received during the most recent treatment Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Sites / Locations
- Veterans Affairs Medical Center - Birmingham
- University of California San Diego Cancer Center
- Veterans Affairs Medical Center - San Francisco
- UCSF Cancer Center and Cancer Research Institute
- CCOP - Christiana Care Health Services
- Lombardi Cancer Center
- Walter Reed Army Medical Center
- CCOP - Mount Sinai Medical Center
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- University of Chicago Cancer Research Center
- Holden Comprehensive Cancer Center at The University of Iowa
- Veterans Affairs Medical Center - Togus
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
- Dana-Farber Cancer Institute
- University of Massachusetts Memorial Medical Center
- Veterans Affairs Medical Center - Minneapolis
- University of Minnesota Cancer Center
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
- Ellis Fischel Cancer Center - Columbia
- Barnes-Jewish Hospital
- University of Nebraska Medical Center
- CCOP - Southern Nevada Cancer Research Foundation
- Norris Cotton Cancer Center
- Veterans Affairs Medical Center - Buffalo
- Roswell Park Cancer Institute
- CCOP - North Shore University Hospital
- Schneider Children's Hospital at North Shore
- Memorial Sloan-Kettering Cancer Center
- New York Presbyterian Hospital - Cornell Campus
- Mount Sinai Medical Center, NY
- State University of New York - Upstate Medical University
- Veterans Affairs Medical Center - Syracuse
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- Lineberger Comprehensive Cancer Center, UNC
- Veterans Affairs Medical Center - Durham
- Duke Comprehensive Cancer Center
- CCOP - Southeast Cancer Control Consortium
- Comprehensive Cancer Center at Wake Forest University
- Arthur G. James Cancer Hospital - Ohio State University
- Rhode Island Hospital
- University of Tennessee, Memphis Cancer Center
- Veterans Affairs Medical Center - Memphis
- Green Mountain Oncology Group
- Vermont Cancer Center
- Veterans Affairs Medical Center - White River Junction
- Veterans Affairs Medical Center - Richmond
- MBCCOP - Massey Cancer Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006223
First Posted
September 11, 2000
Last Updated
June 20, 2013
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI), Cancer and Leukemia Group B, SWOG Cancer Research Network
1. Study Identification
Unique Protocol Identification Number
NCT00006223
Brief Title
flt3L in Treating Patients With Acute Myeloid Leukemia
Official Title
A Phase III Study of Flt3 Ligand (Flt3L) Therapy in Acute Myeloid Leukemia (AML) Patients in Remission
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI), Cancer and Leukemia Group B, SWOG Cancer Research Network
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Drugs such as flt3L may stimulate a person's immune system and help kill cancer cells. It is not yet known if flt3L is effective in treating acute myeloid leukemia.
PURPOSE: Randomized phase III trial to determine the effectiveness of flt3L in treating patients who have acute myeloid leukemia that is in remission.
Detailed Description
OBJECTIVES:
Compare the failure-free survival and overall survival in patients with acute myeloid leukemia in complete remission treated with maintenance flt3 ligand vs observation alone.
Compare the long-term immunologic effects of these regimens in these patients.
Compare the long-term safety and toxicity of these regimens in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to complete remission (CR) (first vs second vs third or subsequent) and post-remission therapy (yes vs no). Patients are randomized to one of two treatment arms.
Arm I: Patients receive flt3 ligand subcutaneously daily on days 1-14. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm II: Patients undergo observation alone. Patients begin treatment or observation within 4 weeks after documentation of CR after induction therapy or within 4 weeks after discharge from hospital after post-remission therapy.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 139 patients will be accrued for this study within approximately 28 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
adult acute myeloid leukemia in remission, 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 3
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
recombinant flt3 ligand
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of acute myeloid leukemia in first, second, third, or subsequent complete remission (CR)
Must be at least 60 years of age if first CR
Must have had histological proof (from bone marrow aspirate, smears, or touch preps of marrow biopsy) of one of the following prior to achieving CR:
Acute myeloblastic leukemia (M0, M1, M2)
Acute promyelocytic leukemia (M3)
Acute myelomonocytic leukemia (M4)
Acute monocytic leukemia (M5)
Acute erythroleukemia (M6)
Acute megakaryocytic leukemia (M7)
Refractory anemia with excess blasts in transformation
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
ECOG 0-2
Life expectancy:
Not specified
Hematopoietic:
Not specified
Hepatic:
Bilirubin less than 3 times upper limit of normal (ULN)
SGOT less than 3 times ULN
Renal:
Creatinine less than 2 mg/dL
Cardiovascular:
No clinically significant active cardiac disease
Pulmonary:
No clinically significant active pulmonary disease
Other:
Not pregnant or nursing
Fertile patients must use effective contraception
No uncontrolled or active autoimmune disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Prior autologous bone marrow transplantation (BMT) allowed
No prior allogeneic BMT
Other prior immunotherapy allowed if not received during the most recent treatment
Chemotherapy:
Not specified
Endocrine therapy:
Not specified
Radiotherapy:
Not specified
Surgery:
Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob M. Rowe, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Richard A. Larson, MD
Organizational Affiliation
University of Chicago
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
John E. Godwin, MD, MS
Organizational Affiliation
Loyola University
Official's Role
Study Chair
Facility Information:
Facility Name
Veterans Affairs Medical Center - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233-1996
Country
United States
Facility Name
University of California San Diego Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
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
UCSF Cancer Center and Cancer Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0128
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Lombardi Cancer 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
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
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
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
Veterans Affairs Medical Center - Togus
City
Togus
State/Province
Maine
ZIP/Postal Code
04330
Country
United States
Facility Name
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
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 - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-3330
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
Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
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
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
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
Schneider Children's Hospital at North Shore
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 Presbyterian Hospital - Cornell Campus
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
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
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
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
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
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
University of Tennessee, Memphis Cancer Center
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
Green Mountain Oncology Group
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Vermont Cancer Center
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
Veterans Affairs Medical Center - Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
MBCCOP - Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States
12. IPD Sharing Statement
Learn more about this trial
flt3L in Treating Patients With Acute Myeloid Leukemia
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