Azacitidine in Treating Patients With Chronic Myelomonocytic Leukemia
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.
|Leukemia||Drug: azacitidine Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of Azacitidine in Chronic Myelomonocytic Leukemia (CMML)|
- Safety and tolerability
- Overall response rate
- 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
|Study Start Date:||January 2010|
|Study Completion Date:||May 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
- To assess the safety and tolerability of azacitidine in patients with chronic myelomonocytic leukemia (CMML).
- To assess the overall response rate in these patients.
- 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 completion of study treatment, patients are followed up for 1 month.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235117
|Leeds Cancer Centre at St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Beatson West of Scotland Cancer Centre|
|Glasgow, Scotland, United Kingdom, G12 0YN|
|Principal Investigator:||David T. Bowen, MD||Leeds Cancer Centre at St. James's University Hospital|