CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 107 enrolled
Drug / intervention
Conditioning regimen: TBI + Fludarabine +1 moredrug
Likely dose
Conditioning regimen: TBI + Fludarabine 90 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00603954
NCT00603954Phase 2Completed
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Allogeneic Hematopoietic Cell Transplantation With HLA-matched Donors : a Phase II Randomized Study Comparing 2 Nonmyeloablative Conditionings

University of Liege·interventional·Posted Jan 29, 2008·Updated Jan 26, 2022

In Brief

A Phase 2 clinical trial evaluating Conditioning regimen: TBI + Fludarabine and Conditioning regimen:TLI (8 Gy) + ATG for Hematological Malignancies. Completed, enrolled 107 participants across 11 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHematological Malignancies
CountriesBelgium, Netherlands
CollaboratorsMaastricht University Medical Center, KU Leuven

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 29, 2008
Enrollment StartJan 1, 2008
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 18.4 years ago

Interventions

Conditioning regimen: TBI + Fludarabinedrug

2 Gy TBI, Fludarabine 90 mg/m²

Conditioning regimen:TLI (8 Gy) + ATGdrug

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