Sponsor: Nordic MDS group
Principal investigator: Lars Möllgård
Co-principal investigator: Eva Hellström Lindberg
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: Final Protocol June, 2011.
Start: Sweden; March, 2012. Denmark; August, 2012. Norway; July 2013. Finland; October 2014.
Research support: Celgene
- MDS (IPSS Int-2 or High) or AML (multilineage dysplasia and 20-30 % blasts) with a karyotype including del(5q).
- 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.
Target: 72 randomized patients
Number of patients randomized now: 72