enalidomide and 5azacitidine treatment versus 5azacitidine alone in patients with the blood cancers myelodysplastic syndrome or acute myeloid leukaemia
- Conditions
- Myelodysplastic syndromes (MDS)Low marrow blast count acute myeloid leukaemia (AML)Blood - Haematological diseasesCancer - Leukaemia - Acute leukaemia
- Registration Number
- ACTRN12610000271000
- Lead Sponsor
- Australasian Leukaemia and Lymphoma Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 160
Disease diagnosis of either MDS (by World Health Organisation criteria, those with refractory anaemia and Refractory Anaemia with Ringed Sideroblasts to also have at least one clinically significant cytopenia), nonproliferative Chronic Myelomonocytic Leukaemia (CMML) or low marrow blast count AML; Eastern Cooperative Oncology Group (ECOG) 2 or less with life expectancy at least 3 months, adequate contraception and adequate renal and hepatic function, written informed consent.
Prior chemotherapy for MDS or AML except low dose cytarabine or hydroxyurea, any prior demethylating agent or immunomodulatory drug (including thalidomide or lenalidomide), prior diagnosis of cancer except with low risk of recurrence, significant renal, hepatic, cardiac or respiratory disease or severe active infection.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate improved efficacy with the combination of lenalidomide and 5azacitidine compared to 5azacitidine alone in patients with MDS and low marrow blast count AML, with acceptable toxicity of the combination. Outcome will be assessed by measures of disease response as defined by International Working Group (IWG) criteria (2006) and determined by peripheral blood counts, transfusions, bone marrow morphology and cytogenetics.[12 months from start of treatment]
- Secondary Outcome Measures
Name Time Method