- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006223
flt3L in Treating Patients With Acute Myeloid Leukemia
A Phase III Study of Flt3 Ligand (Flt3L) Therapy in Acute Myeloid Leukemia (AML) Patients in Remission
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.
Study Overview
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.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233-1996
- Veterans Affairs Medical Center - Birmingham
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California
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La Jolla, California, United States, 92093-0658
- University of California San Diego Cancer Center
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San Francisco, California, United States, 94121
- Veterans Affairs Medical Center - San Francisco
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San Francisco, California, United States, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Delaware
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Wilmington, Delaware, United States, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, United States, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, United States, 20007
- Lombardi Cancer Center
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Florida
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Miami Beach, Florida, United States, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, United States, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, United States, 60637-1470
- University of Chicago Cancer Research Center
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Iowa
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Iowa City, Iowa, United States, 52242-1009
- Holden Comprehensive Cancer Center at the University of Iowa
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Maine
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Togus, Maine, United States, 04330
- Veterans Affairs Medical Center - Togus
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Maryland
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Baltimore, Maryland, United States, 21201
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts Memorial Medical Center
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Minnesota
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Minneapolis, Minnesota, United States, 55417
- Veterans Affairs Medical Center - Minneapolis
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Cancer Center
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Missouri
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Columbia, Missouri, United States, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
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Columbia, Missouri, United States, 65203
- Ellis Fischel Cancer Center - Columbia
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Saint Louis, Missouri, United States, 63110
- Barnes-Jewish Hospital
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Nebraska
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Omaha, Nebraska, United States, 68198-3330
- University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, United States, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center
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New York
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Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
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Buffalo, New York, United States, 14215
- Veterans Affairs Medical Center - Buffalo
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Manhasset, New York, United States, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, United States, 11030
- Schneider Children's Hospital at North Shore
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, United States, 10021
- New York Presbyterian Hospital - Cornell Campus
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New York, New York, United States, 10029
- Mount Sinai Medical Center, NY
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Syracuse, New York, United States, 13210
- State University of New York - Upstate Medical University
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Syracuse, New York, United States, 13210
- Veterans Affairs Medical Center - Syracuse
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Syracuse, New York, United States, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, United States, 27705
- Veterans Affairs Medical Center - Durham
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, United States, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, United States, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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Tennessee
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Memphis, Tennessee, United States, 38103
- University of Tennessee, Memphis Cancer Center
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Memphis, Tennessee, United States, 38104
- Veterans Affairs Medical Center - Memphis
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Vermont
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Bennington, Vermont, United States, 05201
- Green Mountain Oncology Group
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Burlington, Vermont, United States, 05401-3498
- Vermont Cancer Center
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White River Junction, Vermont, United States, 05009
- Veterans Affairs Medical Center - White River Junction
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Virginia
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Richmond, Virginia, United States, 23298-0037
- MBCCOP - Massey Cancer Center
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Richmond, Virginia, United States, 23249
- Veterans Affairs Medical Center - Richmond
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Investigators
- Study Chair: John E. Godwin, MD, MS, Loyola University
- Study Chair: Richard A. Larson, MD, University Of Chicago
- Study Chair: Jacob M. Rowe, MD, Rambam Health Care Campus
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- adult acute myeloid leukemia in remission
- adult acute erythroid leukemia (M6)
- adult acute megakaryoblastic leukemia (M7)
- adult acute minimally differentiated myeloid leukemia (M0)
- adult acute monoblastic leukemia (M5a)
- adult acute monocytic leukemia (M5b)
- adult acute myeloblastic leukemia with maturation (M2)
- adult acute myeloblastic leukemia without maturation (M1)
- adult acute myelomonocytic leukemia (M4)
- adult acute promyelocytic leukemia (M3)
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000068143
- ECOG-2998
- CALGB-19903
- SWOG-E2998
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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