Azacitidine, Lenalidomide and DLI as Salvage Therapy for MDS, CMML and sAML Relapsing After Allo-HSCT
Status:
Completed
Trial end date:
2020-04-23
Target enrollment:
Participant gender:
Summary
This is a prospective, open-label, single-arm multi-center phase II study aiming to evaluate
the safety and feasibility of the addition of Lenalidomide (investigational drug) to the
standard therapy of Azacitidine and DLI (standard of care) as first salvage therapy for
relapse of MDS, CMML and AML with MDS-related changes (sAML, with 20%-30% bone marrow blasts,
formerly RAEB-T) after allo-SCT. The starting dose of Lenalidomid is 2.5 mg per day for 21
days with a 7 day rest. The study incorporates 2 interim safety analyses after 10 and 20
patients in order to find the optimal and safe dose of Lenalidomide.