drugset / Trial / NCT01063647

Dose-range Finding Treosulfan-based Conditioning

NCT01063647

Phase 1/2 Completed 56 enrolled medac GmbH
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Evaluation of the safety and efficacy of 3 x 10, 3 x 12 or 3 x 14 g/m² Treosulfan resp., combined with 5 x 30 mg/m² fludarabine prior to allogeneic, hematopoietic stem cell transplantation of patients with hematological malignancies, but non-eligible to standard conditioning treatment.

Timeline

Start
2001-11
Primary completion
2005-06
Completion
2006-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Treosulfan Small molecule 10 g Intravenous
Subject Treosulfan Small molecule 12 g Intravenous
Subject Treosulfan Small molecule 14 g Intravenous