High Dose Cytarabine And Mitoxantrone Therapy For Relapsed And Refractory Acute Myeloid And Lymphocytic Leukemia: Effects Of GM-CSF Versus G-CSF On Dendritic Cells And Leukemia Associated Antigen-Specific T-Lymphocytes
- Compare amounts of dendritic cells and leukemia-associated antigen-specific T
lymphocytes in patients with relapsed or refractory acute myeloid leukemia or acute
lymphoblastic leukemia treated with filgrastim (G-CSF) vs sargramostim (GM-CSF) after
high-dose cytarabine and mitoxantrone.
OUTLINE: This is a randomized study.
All patients receive high-dose cytarabine IV over 1 hour twice daily on days 1-6 and
mitoxantrone IV over 30 minutes on days 2-4. On day 6, patients are randomized to 1 of 2
- Arm I: Patients receive filgrastim (G-CSF) subcutaneously (SC) daily until blood counts
recover in the absence of unacceptable toxicity.
- Arm II: Patients receive sargramostim (GM-CSF) SC daily as in arm I.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 6 years.
Allocation: Randomized, Primary Purpose: Treatment
Maria R. Baer, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|