Azacitidine in Treating Patients With Chronic Myelomonocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT01235117|
Recruitment Status : Completed
First Posted : November 5, 2010
Last Update Posted : August 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: azacitidine Other: laboratory biomarker analysis||Phase 2|
- 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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Official Title:||A Phase 2 Study of Azacitidine in Chronic Myelomonocytic Leukemia (CMML)|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||May 2013|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|