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Cyclophosphamide

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FM-PTCy conditioning will consist in IV fludarabine 30 mg/m2 on days -6, -5, -4, -3, and -2 (total dose 150 mg/m2), melphalan given at the dose of 100 mg/m2 on day -2, and cyclophosphamide 50 mg/kg on days +3 and +4.

FM-ATG conditioning will consist in IV fludarabine 30 mg/m2 on days -6, -5, -4, -3, and -2 (total dose 150 mg/m2), melphalan given at the dose of 100 mg/m2 on day -2, and ATG (Thymoglobulin®, Genzyme), at a dose of 2.5 mg/kg/d on days -2 and -1.

ATG: 2.5 mg /kg/day on day -2 and -1 (day 0 is allogenic transplantation)

Cyclophosphamid

Frédéric Baron, MD,Ph

Dimitri Breems, MD PhD

Dominik Selleslag, MD, PhD

Philippe Lewalle, MD PhD

Ann De Becker, MD PhD

Rik Schots, MD PhD

Xavier Poiré, MD

Tessa Kerre, MD PhD

Johan Maertens, MD PhD

Hélène Schoemans, MD PhD

Frédéric Baron, MD, PhD

Yves Beguin, MD, PhD

Evelyne Willems, MD

Sophie Servais, MD

Dries Deeren, MD

Carlos Graux, MD PhD

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.

Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning

Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning: a Phase II Randomized Study From the Belgian Hematology Society (BHS)

To assess hematopoietic (whole blood and T cell chimerism) engraftment in the 2 arms.

To assess the quality of immunologic reconstitution in the 2 arms

To assess the timing (days) of immunologic reconstitution in the 2 arms

To assess the incidences of bacterial infections (number of episode, site, grade) in the 2 arms, in the whole group of patients

To assess the incidences of fungal infections (number of episode, site, grade) in the 2 arms, in the whole group of patients

To assess the incidences of viral infections (number of episode, site, grade) in the 2 arms, in the whole group of patients

To assess kinetics of functional ATG serum levels (mg/L) in the FM-ATG arm

To assess kinetics of functional ATG serum levels (mg/L) in the FM-ATG arm in association with cGRFS

To assess kinetics of functional ATG serum levels (mg/L) in the FM-ATG arm in association with NRM

To assess kinetics of functional ATG serum levels (mg/L) in the FM-ATG arm in association with OS

To assess kinetics of functional ATG serum levels (mg/L) in the FM-ATG arm in association with Relapse/progression

To assess kinetics of functional ATG serum levels (mg/L) in the FM-ATG arm in association with Infections

To assess kinetics of functional ATG serum levels (mg/L) in the FM-ATG arm in association with immunologic reconstitution (CD4 and NAIVE T cells counts)

To assess the current GVHD-free, relapse-free survival (cGRFS) for patients in the 2 arms

To assess cGRFS for patients conditioned with FM-PTCy or FM-ATG separately in those transplanted with a related or an unrelated donor

To assess the relapse/progression rate for patients conditioned with FM-PTCy or FM-ATG

To assess rate of grade II-IV and III-IV acute GVHD (Graft-versus-host disease) in patients conditioned with FM or FM-ATG.

To assess rate of grade of moderate-severe chronic GVHD in patients conditioned with FM or FM-ATG.

To assess rate of Nonrelapse Mortality in patients conditioned with FM-PTCy or FM-ATG.

To assess rate of Leukemia Free Survival in patients conditioned with FM-PTCy or FM-ATG.

To assess rate of Overall Survival in patients conditioned with FM-PTCy or FM-ATG.

To assess the proportion of patients alive without active disease and without systemic immunosuppression

Spots Global Cancer Trial Database for acute lymphoid leukemia in remission