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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
ATG: 2.5 mg /kg/day on day -2 and -1 (day 0 is allogenic transplantation)
100mg/m² on day -2
30mg/m² on days -6, -5, -4, -3, and -2
50 mg/kg on days +3 and +4.
ZNA Stuivenberg
Antwerp, Belgium
RECRUITINGAZ Sint Jan Brugge
Bruges, Belgium
RECRUITINGIJ Bordet
Brussels, Belgium
RECRUITINGUZ Brussel
Brussels, Belgium
RECRUITINGUCL St Luc
Brussels, Belgium
RECRUITINGUZ Gent
Ghent, Belgium
RECRUITINGUZ Leuven
Leuven, Belgium
RECRUITINGCHU de Liège
Liège, Belgium
RECRUITINGAZ Delta Roeselare
Roeselare, Belgium
RECRUITINGCHU UCL Namur Godinne
Yvoir, Belgium
RECRUITINGCurrent GVHD-free, relapse-free survival (cGRFS)
To assess the current GVHD-free, relapse-free survival (cGRFS) for patients in the 2 arms
Time frame: 15 years (the primary endpoint will be first assessed after 191 events have been reached)
cGRFS according donor
To assess cGRFS for patients conditioned with FM-PTCy or FM-ATG separately in those transplanted with a related or an unrelated donor
Time frame: 15 years
Relapse/progression rate
To assess the relapse/progression rate for patients conditioned with FM-PTCy or FM-ATG
Time frame: 15 years
Rate aGVHD
To assess rate of grade II-IV and III-IV acute GVHD (Graft-versus-host disease) in patients conditioned with FM or FM-ATG.
Time frame: 6 months
Rate cGVHD
To assess rate of grade of moderate-severe chronic GVHD in patients conditioned with FM or FM-ATG.
Time frame: 24 months
Rate of Nonrelapse Mortality (NRM)
To assess rate of Nonrelapse Mortality in patients conditioned with FM-PTCy or FM-ATG.
Time frame: 15 years
Rate of Leukemia Free Survival (LFS)
To assess rate of Leukemia Free Survival in patients conditioned with FM-PTCy or FM-ATG.
Time frame: 15 years
Rate of Overall Survival (OS)
To assess rate of Overall Survival in patients conditioned with FM-PTCy or FM-ATG.
Time frame: 15 years
Proportion of patients alive
To assess the proportion of patients alive without active disease and without systemic immunosuppression
Time frame: 15 years
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