Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
RATIONALE: Drugs used in chemotherapy, such as mitoxantrone, cytarabine, and etoposide, 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 combination chemotherapy works in treating patients with newly diagnosed acute myeloid leukemia.
|Leukemia||Biological: filgrastim Drug: cytarabine Drug: etoposide Drug: mitoxantrone hydrochloride||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Intensive Induction for Newly Diagnosed Acute Myelogenous Leukemia|
|Study Start Date:||June 2001|
|Study Completion Date:||May 2008|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
- Determine the complete remission rate in patients with acute myelogenous leukemia treated with induction chemotherapy comprising mitoxantrone hydrochloride, cytarabine, and etoposide.
- Determine the feasibility and toxicity of this regimen when given to patients with newly diagnosed acute myelogenous leukemia.
OUTLINE: Patients receive induction chemotherapy comprising mitoxantrone hydrochloride IV on days 1-3, cytarabine IV continuously over 72 hours on days 1-3 and 8-10, and etoposide IV continuously over 72 hours on days 8-10. Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 4 and continuing until blood counts recover.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274807
|Study Chair:||Matt E. Kalaycio, MD||The Cleveland Clinic|