drugset / Trial / NCT01423175

ClAraC or FLAMSA Followed by Stem Cell Transplantation to Treat High Risk AML or Advanced MDS

NCT01423175

RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2011-07
Primary completion
2015-01
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Clofarabine Other / unclassified
Subject Cytarabine Small molecule
Comparator amsacrine Small molecule
Comparator fudarabine Unknown