ACTRN12610000271000
Completed
Phase 2
A Randomised Phase II study comparing the efficacy of 5azacitidine alone versus combination therapy with lenalidomide and 5azacitidine in patients with higher risk myelodysplastic syndromes (MDS) and low marrow blast count acute myeloid leukaemia (AML).
Australasian Leukaemia and Lymphoma Group0 sites160 target enrollmentApril 1, 2010
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Myelodysplastic syndromes (MDS)
- Sponsor
- Australasian Leukaemia and Lymphoma Group
- Enrollment
- 160
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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