NCT01423175

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

Randomized, Multi-centre, Phase II Trial to Compare the Event-Free Survival of Clofarabine / Ara-C (ClAraC) or of FLAMSA Treatment in Patients With High Risk AML or Advanced MDS Scheduled for Allogeneic Stem Cell Transplantation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Myeloid Leukemia
• MDS

Interventions

Type	Name	Description
DRUG	Clofarabine, ara-C
DRUG	FLAMSA

Timeline

• Start date: 2011-07-01
• Primary completion: 2015-01-01
• First posted: 2011-08-25
• Last updated: 2011-08-29

Locations

3 sites across 1 country: Germany