Phase II Study of Risk-Adapted Fludarabine, Melphalan, and Total Body Irradiation Conditioning for Allogeneic Stem Cell Transplantation in Blood Cancers

What this Trial Is About

Researchers are evaluating a new conditioning regimen for allogeneic hematopoietic stem cell transplantation AHSCT in patients with blood cancers like AML, ALL, MDS, CML, NHL, HD, and CLL. This phase II study aims to tailor treatment based on patient risk, age, and health status to improve outcomes. The study is sponsored by the University of California, Irvine, and focuses on safety and effectiveness over a two-year follow-up period. Participants will receive a stem cell transplant after a conditioning treatment combining fludarabine, melphalan, and total body irradiation TBI. The doses of melphalan and TBI vary according to each patients Hematopoietic Cell Transplant Composite Risk score, age, and performance status. Additional medications after transplant include high-dose cyclophosphamide, tacrolimus, and mycophenolate mofetil to help prevent graft-versus-host disease. During the study, patients will be monitored closely for safety and treatment effects for up to two years after transplantation. Researchers will measure progression-free survival as the main outcome, along with overall survival, relapse rates, graft-versus-host disease incidence, and drug exposure levels. Assessments include health evaluations and laboratory tests to track patient condition and transplant success throughout the follow-up period.

Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation