Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation
Start Date
9/11/2023
Completion Date
9/1/2027
Summary
This is a prospective, single-arm, phase II study. Patients will be treated with an allogeneic stem cell transplantation (AHSCT) using fludarabine, melphalan and total body irradiation (TBI) conditioning with different melphalan and TBI doses based on patient- and disease-related risk.
Detailed Description
Eligible patients will receive an allogeneic stem cell transplantation using a combination of fludarabine, melphalan and total body irradiation (TBI) conditioning regimen and post-transplant high dose cyclophosphamide (PTCY), tacrolimus and mycophenolate mofetil (MMF) for graft-versus-host prophylaxis. Melphalan and TBI doses will be tailored based on the Hematopoietic Stem Cell Transplant- Composite Risk (HCT-CR), age and Karnofski performance status (KPS). Melphalan dose ranges from 100 -140 mg/m2 while TBI dose ranges from 2-5 Gy. All patients will be monitored for safety and efficacy up to 2 years post-transplantation.
Eligibility Criteria
Age Range: 18 years to 70 years
Interventions
Fludarabine
Melphalan
Total Body Irradiation
Conditions
Locations
Chao Family Comprehensive Cancer Center, University of California Irvine
Orange, California 92868
United States