ClAraC or FLAMSA Followed by Stem Cell Transplantation to Treat High Risk AML or Advanced MDS
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
ClAraC (consisting of one dose of clofarabine and ara-C for five days) or FLAMSA (consisting
of one dose of fudarabine, amsacrine and ara-C for four days) will be administered followed
by reduced-intensity conditioning regimen (RIC) in the setting of allogeneic stem cell
transplantation (SCT). The aim of the study is to explore the antileukemic, immunosuppressive
effects and toxicity and safety of clofarabine in combination with ara-C in the setting of
RIC allogeneic transplantation compared with the FLAMSA-protocol for patients with high-risk
acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS).
Phase:
Phase 2
Details
Lead Sponsor:
Hannover Medical School
Collaborators:
Genzyme, a Sanofi Company Hannover Clinical Trial Center GmbH