NMDSG10B. A multicentre open randomized phase II study of the efficacy and safety of azacitidine alone or in combination with lenalidomide in high-risk myeloid disease (high-risk MDS and AML) with a karyotype including del(5q).
Sponsor: Nordic MDS group
Principal investigator: Lars Möllgård
Co-principal investigator: Eva Hellström-Lindberg, David Bowen
Primary endpoint: Hematologic response after 6 cycles of azacitidine or azacitidine+lenalidomide treatment
Co-primary endpoint: Cytogenetic response (FISH) after 6 cycles of azacitidine or azacitidine+lenalidomide treatment
Status: Protocol writing
Start: Expected accrual time, FPI Q3 2011
Research support: Celgene
Inclusion critera:
- MDS (IPSS Int-2 or High) or AML (multilineage dysplasia and 20-30 % blasts) with a karyotype including del(5q).
Exclusion criteria:
- Eligible for upfront allogeneic SCT without prior chemotherapy including azacytidine
- Prior therapy with lenalidomide
Treatment: Patients will be randomized to azacitidine (Arm A) or azacitidine + lenalidomide (Arm B) in increasing doses for 6 cycles.
Contact person: Bengt Rasmussen
E-mail: bengt.rasmussen@orebroll.se
Last update: 2011-03-16 | 
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