Dose-range Finding Treosulfan-based Conditioning

NCT01063647 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-11-03

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01063647 on ClinicalTrials.gov