Leukemia Clinical Trial
Official title:
A Phase 2 Study of Azacitidine in Chronic Myelomonocytic Leukemia (CMML)
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.
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
;
Allocation: Non-Randomized, Primary Purpose: Treatment
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