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Treosulfan-based Versus Busulfan-based Conditioning in Paediatric Patients With Non-malignant Diseases

NCT02349906 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2025-12-08

No results posted yet for this study

Summary

The aim of the trial is to describe the safety and efficacy of intravenous (i.v.) Treosulfan compared to the conventional (myeloablative) dose of i.v. Busulfan, each administered as part of a standardised Fludarabine-containing conditioning regimen and to contribute to a PK model which permits - in conjunction with data comparing Treosulfan and Busulfan in adults with malignant diseases - to extend the use of Treosulfan in the paediatric population by extrapolating efficacy.

Conditions

Interventions

DRUG

Treosulfan

DRUG

Busilvex

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Venn Life Sciences

    collaborator OTHER

  • Syneos Health

    collaborator OTHER

  • medac GmbH

    lead INDUSTRY

Principal Investigators

  • Karl-Walter Sykora, MD and Prof · Hannover Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Days
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2020-05-07
Completion
2023-02-13

Countries

  • Czechia
  • Germany
  • Italy
  • Poland

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02349906 on ClinicalTrials.gov