Trials / Completed
CompletedNCT01235117
Azacitidine in Treating Patients With Chronic Myelomonocytic Leukemia
A Phase 2 Study of Azacitidine in Chronic Myelomonocytic Leukemia (CMML)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- University of Leeds · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | azacitidine | |
| OTHER | laboratory biomarker analysis |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2012-12-01
- Completion
- 2013-05-01
- First posted
- 2010-11-05
- Last updated
- 2013-08-26
Locations
2 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01235117. Inclusion in this directory is not an endorsement.