Azacitidine in Treating Patients With Chronic Myelomonocytic Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT01235117
- Lead Sponsor
- University of Leeds
- 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 Description
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 completion of study treatment, patients are followed up for 1 month.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability Overall response rate
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, Scotland, United Kingdom