A Phase II Study of Gemcitabine/ Mitoxantrone in Patients With AML in First Relapse
- 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.
- 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
- 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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response rate and incomplete blood count recovery
Assumptions/ hypothesis: A CR rate of 30% or less is unacceptable, and 50% or more is promising. A two-stage design will be used. Initially, 18 patients will be enrolled. If 5 or fewer achieve CR, the study will be stopped. Otherwise, an additional 22 patients will be accrued. Four weeks is anticipated for observation for response.Please refere to published Article in Clinical Lymphoma, Myeloma& leukemia December 2010
Anjali Advani, MD
The Cleveland Clinic
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|