Spots Global Cancer Trial Database for Gemcitabine and Mitoxantrone in Treating Patients With Relapsed Acute Myeloid Leukemia

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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