Chronic myelomonocytic leukaemia Cancer Myeloid leukaemia
Conditions
Interventions
Patients should be assessed for their suitability for treatment on Day -5 to Day 1 (start of treatment) of each cycle. Patients should be pre-medicated with ondansentron as per local anti-emetic polic
responders may continue drug administration until loss of response or development of unacceptable toxicity.
Sponsors
Leeds Teaching Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with newly diagnosed or previously treated CMML-1 or CMML-2 according to World Health Organization (WHO) criteria (2008) 2. Subject is able and willing to sign the informed consent form 3. Age 18 years or over, either sex, at the time of signing the informed consent form 4. WHO performance status of less than or equal to 2 at study entry 5. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days prior to start of study drug 6. WCBP and men with WCBP partners must agree to use adequate contraceptive methods while on study drug and 6 months after the end of the study
Exclusion criteria
Exclusion criteria: 1. CMML with eosinophilia and 5q33 abnormality 2. Previous chemotherapy for CMML except hydroxycarbamide 3. Creatinine concentration more than 1.5 x the institutional upper limit of the normal range 4. Pregnant or lactating females 5. Use of any other experimental drug or therapy within 28 days of baseline 6. Known hypersensitivity to azacitidine 7. Other active malignant disease 8. Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type B or C 9. Active infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the safety and tolerability of 5-azacitidine, monitored throughout the trial 2. To assess the overall response rate, measured at the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess response of disease to 5-azacitidine, specifically: 1. Incidence of complete remission (CR)/partial remission(PR) 2. Haematological improvement 3. Control of myeloproliferation 4. Incidence of reduction in spleen size by greater than 50% 5. Overall survival 6. Time to acute myeloid leukaemia (AML) transformation of CMML 7. Time to death or AML transformation of CMML 8. Biological correlates All monitored throughout the trial. | — |
Countries
England, United Kingdom
Outcome results
None listed