NCT06083129View on ClinicalTrials.gov

Phase III Study Comparing GVHD Prophylaxis With ATG-thymoglobulin to ATLG-grafalon in Elderly Patients With Acute Myeloid Leukemia or Myelodysplasic Syndrome and Receiving an Allogeneic Hematopoietic Stem Cell Transplantation With a 10/10 HLA Matched Unrelated Donor

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

324

Participants

Timeline

Start Date

November 1, 2023

Primary Completion Date

February 15, 2027

Study Completion Date

November 1, 2028

Conditions
GVHD
Interventions
DRUG

Grafalon

10 mg/Kg/day IV for 3 consecutive days (day-3 to -1 before transplantation)

DRUG

Thymoglobulin

2.5 mg/Kg/day IV for 2 consecutive days (day-3 and -2 before transplantation)

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT06083129 - Phase III Study Comparing GVHD Prophylaxis With ATG-thymoglobulin to ATLG-grafalon in Elderly Patients With Acute Myeloid Leukemia or Myelodysplasic Syndrome and Receiving an Allogeneic Hematopoietic Stem Cell Transplantation With a 10/10 HLA Matched Unrelated Donor | Biotech Hunter | Biotech Hunter