Phase II Study of Reduced Intensity Conditioning and Post-Transplant Cyclophosphamide for Allogeneic Stem Cell Transplant in Blood Cancers

What this Trial Is About

This trial investigates a Phase II treatment approach for patients with various blood cancers using a reduced intensity conditioning regimen followed by allogeneic stem cell transplant. The study focuses on subjects receiving a non-myeloablative preparative regimen of cyclophosphamide, fludarabine, and total body irradiation, followed by donor stem cell infusion with graft-versus-host disease GVHD prevention using post-transplant cyclophosphamide, sirolimus, and mycophenolate mofetil. The aim is to evaluate rates of acute and chronic GVHD along with other transplant outcomes in patients up to 75 years old. Participants receive conditioning with fludarabine and cyclophosphamide administered intravenously on specific days before and after transplant, combined with a single dose of total body irradiation. On the day of transplant, patients receive an infusion of either peripheral blood stem cells or bone marrow cells from a related, unrelated, or partially matched family donor. GVHD prophylaxis begins shortly after transplant with oral sirolimus and mycophenolate mofetil given over several weeks. Allopurinol is also administered prior to transplant to support treatment. Throughout the study, participants will be closely monitored for signs of acute and chronic GVHD for up to 12 months and for relapse rates within 100 days post-transplant. Long-term survival will be observed for up to 72 months, and transplant-related mortality will be tracked for 12 months. Assessments include clinical evaluations, laboratory tests, and imaging as needed. The total participation duration may extend over several years to fully capture treatment outcomes and safety.

Allo HSCT Using RIC and PTCy for Hematological Diseases