Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide in Patients With Hematological Malignancies (The COmPACt Study)

What this Trial Is About

Researchers are evaluating an alternative approach for preventing graft-versus-host disease (GVHD) in patients undergoing cord blood (CB) transplantation for hematological malignancies. This study aims to improve immune recovery and reduce complications such as viral reactivation and post-transplant lymphoproliferative diseases, which are associated with the current standard treatment involving anti-thymocyte globulin. The primary focus is on patients receiving matched CB transplants with myeloablative conditioning regimens and post-transplant cyclophosphamide. Participants receive CB transplantation combined with a myeloablative conditioning regimen, involving drugs like Thiotepa, Busulfan, Fludarabine, or total body irradiation with Fludarabine. GVHD prevention includes post-transplant cyclophosphamide given on days +3 and +5, along with cyclosporine and mycophenolate mofetil. The study evaluates hematopoietic engraftment, immune recovery, and GVHD incidence and severity following this treatment approach. During the study, researchers will monitor blood cell recovery, including neutrophil and platelet counts, and measure CD4+ cell levels at day 100 post-transplant. They will also assess the occurrence and severity of acute and chronic GVHD. Participant involvement includes regular clinical and laboratory evaluations to track immune system recovery and transplant outcomes until at least 100 days after transplant, with safety and efficacy closely observed throughout the process.

Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide (COmPACt Study)