NCT01063647

Dose-range Finding Treosulfan-based Conditioning

Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Advanced Hematological Malignancies After Treosulfan-based Conditioning Therapy - A Clinical Phase II Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: medac GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematological Malignancies

Interventions

Type	Name	Description
DRUG	Treosulfan	10 g/m² i.v. infusion, day -6, -5, -4
DRUG	Treosulfan	12 g/m² i.v. infusion, day -6, -5, -4
DRUG	Treosulfan	14 g/m² i.v. infusion, day -6, -5, -4

Timeline

• Start date: 2001-11-01
• Primary completion: 2005-06-01
• Completion: 2006-06-01
• First posted: 2010-02-05
• Last updated: 2023-11-03

Locations

7 sites across 4 countries: Finland, Germany, Poland, Sweden