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Clinical Phase III Trial Treosulfan-based Conditioning Versus Reduced-intensity Conditioning (RIC)

NCT00822393 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 570

Last updated 2020-07-30

No results posted yet for this study

Summary

This randomized allogeneic transplantation protocol compares i.v. Treosulfan-based conditioning therapy with reduced intensity i.v. Busulfan-based conditioning in adult AML and MDS patients at increased risk for standard conditioning therapies. The protocol is based on results of previous phase I/II trials evaluating Treosulfan/Fludarabine conditioning prior to allogeneic haematopoietic stem cell transplantation. The reference arm (reduced intensity i.v. Busulfan/Fludarabine) is considered to be accepted medical practice for the study patient population.

Conditions

Interventions

DRUG

Busulfan

4 x 0.8 mg/kg/d Intravenous Day -4 and -3

DRUG

Treosulfan

10 g/m2/d Intravenous Day -4, -3, -2

Sponsors & Collaborators

  • medac GmbH

    lead INDUSTRY

Principal Investigators

  • Dietrich W. Beelen, MD · University Hospital, Essen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-24
Primary Completion
2018-01-25
Completion
2018-01-25

Countries

  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Poland

Study Locations

More Related Trials

Entities

Diseases

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 NCT00822393 on ClinicalTrials.gov