Gemcitabine and Mitoxantrone in Treating Patients With Relapsed Acute Myeloid Leukemia
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.
Drug: gemcitabine hydrochloride
Drug: mitoxantrone hydrochloride
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Gemcitabine/ Mitoxantrone in Patients With AML in First Relapse|
- Complete response rate and incomplete blood count recovery [ Time Frame: 5 years ] [ Designated as safety issue: No ]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
- Disease-free and overall survival [ Time Frame: Day 11-14 ] [ Designated as safety issue: No ]Secondary endpoints include: evaluating toxicity, assessing the Day 11-14 nadir bone marrow. .After CR is achieved, patients will be followed at 3 months intervals for disease progression and survival. If patient has disease progression after achieving CR, survival will be captured at 6 month intervals.
- Assess hematologic and non-hematologic toxicity [ Time Frame: Day 1- Day 42 ] [ Designated as safety issue: Yes ]Any non-hematologic Grade 4 toxicity lasting longer than 5 days or grade 3 lasting longer than 1 week, excluding alopecia, constitutional symptoms, mucositis controlled with analgesia, febrile neutropenia, and use of TPN.Any treatment related death. Time to recover an absolute neutrophil count of > 500 greater than 35 days (with no evidence of leukemia on bone marrow aspirate/ biopsy).
- Assess laboratory correlates of drug resistance at baseline [ Time Frame: Day 1- Day 42 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Drug: gemcitabine hydrochloride
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268242
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Anjali Advani, MD||The Cleveland Clinic|