Cyclophosphamide Versus Anti-thymocyte Globulin for GVHD Prophylaxis After RIC Allo-SCT

PHASE2CompletedINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

April 6, 2017

Primary Completion Date

October 12, 2020

Study Completion Date

October 12, 2020

Conditions
Graft vs Host Disease
Interventions
DRUG

Cyclophosphamide

GVHD prophylaxis: All patients will receive post-transplant 50mg/Kg/day cyclophosphamide (day +3 and +4) AND cyclosporine-A alone in case of an HLA-sibling donor, or cyclosporine-A and mycophenolate-mofetil in case of an HLA-matched unrelated donor

DRUG

Anti-Thymocyte Globulin

GVHD prophylaxis: 2.5 mg/Kg/day ATG (Thymoglobuline®) for 2 consecutive days (day -2 and -1) All patients will receive cyclosporine-A alone in case of an HLA-sibling donor, or cyclosporine-A and mycophenolate-mofetil (MMF) in case of an HLA-matched unrelated donor.

DRUG

Conditioning regimen

30 mg/m2/day fludarabine for 5 days (day-6 to day-2) 130 mg/m2/day IV busulfan once daily for 2 days (day -4 and -3)

Trial Locations (1)

75012

Saint Antoine Hospital - Hematology Department, Paris

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT02876679 - Cyclophosphamide Versus Anti-thymocyte Globulin for GVHD Prophylaxis After RIC Allo-SCT | Biotech Hunter | Biotech Hunter