Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Phase 2

Completed

• Conditions: Leukemia

• Registration Number: NCT00274807
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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.

Study Timeline

• Study Start: 2001-06
• Study First Submitted: 2006-01-10
• Study First Submitted QC: 2006-01-10
• Study First Posted: 2006-01-11
• Primary Completion: 2007-04
• Study Completion: 2008-05
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-09
• Last Update Posted: 2011-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP