Leukemia Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Colony-stimulating factors such as filgrastim and sargramostim
may increase the number of immune cells found in bone marrow or peripheral blood and may
help a person's immune system recover from the side effects of chemotherapy. It is not yet
known whether combination chemotherapy is more effective followed by filgrastim or
sargramostim in treating leukemia.
PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy
followed by filgrastim with that of combination chemotherapy followed by sargramostim in
treating patients who have relapsed or refractory acute myeloid leukemia or acute
lymphoblastic leukemia.
OBJECTIVES:
- 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
treatment arms.
- 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
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