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Clinical Trial Summary

The present project aims at comparing two conditioning regimens (FM-PTCy vs FM-ATG). The hypothesis is that one or the two regimens will lead to a 2-year cGRFS rate improvement from 30% (the cGRFS rate with FM without ATG/PTCy) to 45% (Pick-a-winner phase 2 randomized study).


Clinical Trial Description

This study is a multicenter, randomized, open-label, phase II study pick-a-winner study, comparing 2 conditioning regimens. A total of 114 eligible patients with HLA-matched donors will be randomized 1:1 between the FM-PTCy arm and the FM-ATG arm, with stratification for donor type (related or unrelated). The recruitment period is 3 years with a 5-year follow-up plus a 10-year additional long-term follow-up (for GVHD status, disease status, second malignancy and QOL). The whole study will be completed within 18 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03852407
Study type Interventional
Source University of Liege
Contact Frédéric Baron, MD,Ph
Phone +32 4 366 72 01
Email F.Baron@uliege.be
Status Recruiting
Phase Phase 2
Start date February 4, 2019
Completion date November 1, 2038

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