flt3L in Treating Patients With Acute Myeloid Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT00006223
- Lead Sponsor
- Eastern Cooperative Oncology Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (47)
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
Schneider Children's Hospital at North Shore
🇺🇸Manhasset, New York, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
New York Presbyterian Hospital - Cornell Campus
🇺🇸New York, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
Veterans Affairs Medical Center - Richmond
🇺🇸Richmond, Virginia, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Birmingham
🇺🇸Birmingham, Alabama, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Veterans Affairs Medical Center - Togus
🇺🇸Togus, Maine, United States
Holden Comprehensive Cancer Center at The University of Iowa
🇺🇸Iowa City, Iowa, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Green Mountain Oncology Group
🇺🇸Bennington, Vermont, United States
University of Tennessee, Memphis Cancer Center
🇺🇸Memphis, Tennessee, United States
Veterans Affairs Medical Center - Memphis
🇺🇸Memphis, Tennessee, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Veterans Affairs Medical Center - White River Junction
🇺🇸White River Junction, Vermont, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States