flt3L in Treating Patients With Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT00006223|
Recruitment Status : Completed
First Posted : September 3, 2003
Last Update Posted : June 24, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Biological: recombinant flt3 ligand||Phase 3|
- 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 :||Interventional (Clinical Trial)|
|Official Title:||A Phase III Study of Flt3 Ligand (Flt3L) Therapy in Acute Myeloid Leukemia (AML) Patients in Remission|
|Study Start Date :||July 2000|
|Actual Study Completion Date :||January 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006223
|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|