Clinical Trial: Azacitidine in Treating Patients With Chronic Myelomonocytic Leukemia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2 Study of Azacitidine in Chronic Myelomonocytic Leukemia (CMML)
Brief Summary:
RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying the side effects of azacitidine and to see how well it works in treating patients with chronic myelomonocytic leukemia.
Detailed Summary:
OBJECTIVES:
Primary
- To assess the safety and tolerability of azacitidine in patients with chronic myelomonocytic leukemia (CMML).
- To assess the overall response rate in these patients.
Secondary
- To assess the incidence of clinical remission/complete remission or partial response in these patients.
- To assess hematological improvement in patients treated with this drug.
- To assess the overall survival of patients treated with this drug.
- To assess progression-free survival of patients treated with this drug.
- To assess the time to acute myeloid leukemia (AML) transformation of CMML.
- To assess the time to death or AML transformation of CMML.
- To assess the biological correlates.
OUTLINE: This is a multicenter study.
Patients receive azacitidine subcutaneously on days 1-5 and 8-9. Treatment repeats every 4 weeks for at least 6 courses in the absence of loss of response/disease progression or unacceptable toxicity. Patients undergo response evaluation after 6 courses or the last course of treatment. Responders may continue azacitidine until loss of response/disease progression or unacceptable toxicity.
Some patients undergo blood, bone marrow, and buccal swab sample collection periodically for correlative studies.
After
Sponsor: University of Leeds
Current Primary Outcome:
- Safety and tolerability
- Overall response rate
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Incidence of clinical remission/complete remission or partial response according to International Working Group (IWG) criteria
- Hematological improvement according to IWG criteria
- Overall survival
- Progression-free survival
- Time to acute myeloid leukemia (AML) transformation of CMML
- Time to death or AML transformation of CMML
- Biological correlates
Original Secondary Outcome: Same as current
Information By: National Cancer Institute (NCI)
Dates:
Date Received: November 4, 2010
Date Started: January 2010
Date Completion:
Last Updated: August 23, 2013
Last Verified: November 2010