A Phase III Study of Flt3 Ligand (Flt3L) Therapy in Acute Myeloid Leukemia (AML) Patients in Remission
Data Collection
Bone Marrow Diseases+11
+ Leukemia, Erythroblastic, Acute
+ Hematologic Diseases
Treatment Study
Summary
Study start date: July 1, 2000
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 47 locations
Veterans Affairs Medical Center - Birmingham
Birmingham, United StatesOpen Veterans Affairs Medical Center - Birmingham in Google MapsUniversity of California San Diego Cancer Center
La Jolla, United StatesVeterans Affairs Medical Center - San Francisco
San Francisco, United StatesUCSF Cancer Center and Cancer Research Institute
San Francisco, United States