Leukemia Clinical Trial
Official title:
A Phase II Study of Gemcitabine/ Mitoxantrone in Patients With Acute Myeloid Leukemia in First Relapse
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and mitoxantrone, work in
different ways to stop the growth of cancer cells, either by killing the cells or by stopping
them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer
cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with
mitoxantrone works in treating patients with relapsed acute myeloid leukemia.
OBJECTIVES:
Primary
- Determine the complete response (CR) rate (CR and incomplete blood count recovery (CRi))
of patients with acute myeloid leukemia in first relapse treated with gemcitabine
hydrochloride and mitoxantrone hydrochloride.
Secondary
- Evaluate disease free and overall survival of patients with acute myeloid leukemia in
first relapse treated with this particular chemotherapy regimen.
- Assess hematologic and non-hematologic toxicity associated with this regimen.
- Assess laboratory correlates of drug resistance in patients with relapsed acute myeloid
leukemia.
- Assess the percentage of patients receiving subsequent bone marrow transplantation.
OUTLINE: This is an open-label, multicenter study.
Patients receive gemcitabine hydrochloride IV over 12 hours on day 1 and mitoxantrone
hydrochloride IV over 30-60 minutes on days 1, 2, and 3. After completion of a single course
of therapy, patients who achieve a complete response may receive 1 additional course of
therapy at the discretion of the treating physician.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
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