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Allogeneic HCT With HLA-matched Donors : a Phase II Randomized Study Comparing 2 Nonmyeloablative Conditionings

NCT00603954 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2022-01-26

Study results available
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Summary

The present project aims at comparing two nonmyeloablative regimens currently used in 2 major HCT centers in the US for patients with HLA-matched related or unrelated donor: the one from the Seattle group consisting of 2 Gy TBI with fludarabine (90 mg/m²) versus the one from the Stanford group combining 8 Gy TLI with ATG.

Conditions

Interventions

DRUG

Conditioning regimen: TBI + Fludarabine

2 Gy TBI, Fludarabine 90 mg/m²

DRUG

Conditioning regimen:TLI (8 Gy) + ATG

TLI 8 Gy + ATG (Thymoglobulin) 7.5 mg/kg

Sponsors & Collaborators

  • Maastricht University Medical Center

    collaborator OTHER

  • KU Leuven

    collaborator OTHER

  • University of Liege

    lead OTHER

Principal Investigators

  • Frederic Baron, MD, PhD · CHU-ULg

  • Yves Beguin, MD, PhD · CHU-ULg

  • Johan Maertens, MD · KUL

  • Koen Theunissen, MD · KUL

  • Harry Schouten, MD · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Belgium
  • Netherlands

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 NCT00603954 on ClinicalTrials.gov