Phase III Study Comparing ATG-thymoglobulin and ATLG-grafalon for Preventing Graft Versus Host Disease in Patients 50 to 70 Years Old With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Allogeneic Stem Cell Transplantation with a Matched Unrelated Donor Using Fludarabine-Treosulfan Conditioning

What this Trial Is About

Researchers are studying elderly patients with acute myeloid leukemia AML or myelodysplastic syndrome MDS who need an allogeneic hematopoietic stem cell transplantation allo-HSCT using a reduced intensity conditioning RIC regimen. The trial compares two different anti-thymocyte globulin ATG drugs, ATG-thymoglobulin and ATLG-grafalon, to find the best prevention for graft versus host disease GVHD in patients aged 50 to 70 years with matched unrelated donors. This phase III study aims to improve disease control and reduce complications related to GVHD and transplant outcomes in this population. Participants receive conditioning with a fludarabine-treosulfan regimen before transplant. They are randomly assigned to receive either ATLG-grafalon at 10 mgkgday intravenously for 3 days or ATG-thymoglobulin at 2.5 mgkgday intravenously for 2 days before transplantation. Both drugs are given to prevent GVHD, and the study compares their effects on acute GVHD incidence and other transplant outcomes. The treatment period is followed closely to assess immune recovery and complications. During the study, participants are monitored for acute GVHD up to day 100 after transplant, with additional follow-ups up to 24 months for various health measures, including blood cell recovery, immune cell levels, viral reactivations, relapse rates, survival, and quality of life. Researchers collect blood samples and track clinical events such as infections, organ function, and hospitalization days. Safety and tolerability are evaluated throughout, with long-term assessments to understand the overall impact of the two GVHD prevention strategies on transplant success and patient well-being.

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