Leukemia Clinical Trial
Official title:
A Phase III Study of Flt3 Ligand (Flt3L) Therapy in Acute Myeloid Leukemia (AML) Patients in Remission
Verified date | September 2006 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | January 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland |
United States | Green Mountain Oncology Group | Bennington | Vermont |
United States | Veterans Affairs Medical Center - Birmingham | Birmingham | Alabama |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Veterans Affairs Medical Center - Buffalo | Buffalo | New York |
United States | Vermont Cancer Center | Burlington | Vermont |
United States | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina |
United States | University of Chicago Cancer Research Center | Chicago | Illinois |
United States | Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago | Illinois |
United States | Ellis Fischel Cancer Center - Columbia | Columbia | Missouri |
United States | Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia | Missouri |
United States | Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio |
United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
United States | Veterans Affairs Medical Center - Durham | Durham | North Carolina |
United States | Holden Comprehensive Cancer Center at The University of Iowa | Iowa City | Iowa |
United States | University of California San Diego Cancer Center | La Jolla | California |
United States | CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | Norris Cotton Cancer Center | Lebanon | New Hampshire |
United States | CCOP - North Shore University Hospital | Manhasset | New York |
United States | Schneider Children's Hospital at North Shore | Manhasset | New York |
United States | University of Tennessee, Memphis Cancer Center | Memphis | Tennessee |
United States | Veterans Affairs Medical Center - Memphis | Memphis | Tennessee |
United States | CCOP - Mount Sinai Medical Center | Miami Beach | Florida |
United States | University of Minnesota Cancer Center | Minneapolis | Minnesota |
United States | Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | Mount Sinai Medical Center, NY | New York | New York |
United States | New York Presbyterian Hospital - Cornell Campus | New York | New York |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | MBCCOP - Massey Cancer Center | Richmond | Virginia |
United States | Veterans Affairs Medical Center - Richmond | Richmond | Virginia |
United States | Barnes-Jewish Hospital | Saint Louis | Missouri |
United States | UCSF Cancer Center and Cancer Research Institute | San Francisco | California |
United States | Veterans Affairs Medical Center - San Francisco | San Francisco | California |
United States | CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York |
United States | State University of New York - Upstate Medical University | Syracuse | New York |
United States | Veterans Affairs Medical Center - Syracuse | Syracuse | New York |
United States | Veterans Affairs Medical Center - Togus | Togus | Maine |
United States | Lombardi Cancer Center | Washington | District of Columbia |
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 | CCOP - Christiana Care Health Services | Wilmington | Delaware |
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 | University of Massachusetts Memorial Medical Center | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Eastern Cooperative Oncology Group | Cancer and Leukemia Group B, National Cancer Institute (NCI), Southwest Oncology Group |
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