Study Testing Two Conditioning Regimen With a Single Prophylaxis of GVHD by Cyclophosphamide and Methotrexate Post-transplant in Patients Eligible for Matched-donor Allograft Transplantation

PHASE2RecruitingINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

July 18, 2024

Primary Completion Date

October 18, 2027

Study Completion Date

July 18, 2028

Conditions
Graft Versus Host DiseaseHematologic Malignancy
Interventions
DRUG

Methotrexate

15 mg/m² on Day+1 after graft (=Day0) 10 mg/m² 3 days on Day+4/Day+6/Day+11 after graft (=Day0)

DRUG

Post-Transplant Cyclophosphamide

50 mg/kg intravenous 2 days on Day+3/Day+5 after graft (=Day0)

DRUG

Fludarabine

Conditioning regimen: 30 mg/m² Intravenous 5 days from Day-6 to Day-2 (Day-6/Day-5-/Day-4/Day-3/Day-2 before graft (=Day0)

DRUG

Cycophosphamide

Conditioning regimen: 14.5 mg/kg intravenous 2 days on Day-6/Day-5 before graft (=Day0)

DRUG

Anti-Thymoglobulin

Conditioning regimen: 2.5 mg/kg intravenous on Day-2 before graft (=Day0)

RADIATION

total body irradiation

2 grays on Day-1 before graft (=Day0)

OTHER

hematopoietic stem cells

High dose of hematopoietic stem cells derived from peripheral blood on transplantation day (=Day0 graft)

OTHER

Graft nuclear cells

Graft nuclear cells CD3+ cells if needed after transplantation

OTHER

Donor Lymphocytes Injection

DLI with CD3+ if relapse after transplantation or in prevention of relapse

DRUG

Clofarabine

Conditioning regimen: 30 mg/m² Intravenous 5 days from Day-6 to Day-2 (Day-6/Day-5-/Day-4/Day-3/Day-2 before graft (=Day0)

DRUG

Thiotepa

Conditioning regimen: 5 mg/kg Intravenous at Day-6 before graft (=Day0)

DRUG

Busulfan

Conditioning regimen: 3.2 mg/kg Intravenous 2 days at Day-2 and Day-1 before graft (=Day0)

DRUG

Fludarabine

Conditioning regimen: 40 mg/m² intravenous 4 days on Day-5/Day-4/Day-3/Day-2 before graft (=Day0)

Trial Locations (3)

Unknown

RECRUITING

CHU Angers, Angers

RECRUITING

CHU Brest, Brest

RECRUITING

CHU Nantes, Nantes

All Listed Sponsors
lead

Nantes University Hospital

OTHER