Dose-range Finding Treosulfan-based Conditioning
NCT01063647 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2023-11-03
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
Interventions
- 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
Sponsors & Collaborators
-
medac GmbH
lead INDUSTRY
Principal Investigators
-
Mathias Freund, MD · University Hospital Rostock
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-11-30
- Primary Completion
- 2005-06-30
- Completion
- 2006-06-30
Countries
- Finland
- Germany
- Poland
- Sweden
Study Locations
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