flt3L in Treating Patients With Acute Myeloid Leukemia
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 Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Phase III Study of Flt3 Ligand (Flt3L) Therapy in Acute Myeloid Leukemia (AML) Patients in Remission|
|Study Start Date:||July 2000|
|Study Completion Date:||January 2007|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006223
Show 47 Study Locations
|Study Chair:||Jacob M. Rowe, MD||Rambam Health Care Campus|
|Study Chair:||Richard A. Larson, MD||University of Chicago|
|Study Chair:||John E. Godwin, MD, MS||Loyola University|