Study of Cladribine-Bridged Lisaftoclax and Busulfan Conditioning for Stem Cell Transplant in Older Patients with Relapsed or Refractory AML and MDS

What this Trial Is About

Researchers are investigating a conditioning treatment regimen for elderly patients with relapsed or refractory acute myeloid leukemia AML and myelodysplastic syndromes MDS. This study focuses on the Clad-LABu regimen, which combines cladribine bridged lisaftolax and busulfan, aiming to improve transplant outcomes and reduce toxicity in allogeneic hematopoietic stem cell transplantation HSCT. The trial is motivated by the poor prognosis and rising incidence of AML in older adults and the need for better tolerability and efficacy in this population. Participants will receive the Clad-LABu conditioning regimen before undergoing allogeneic HSCT. The regimen includes intravenous cladribine and cytarabine, oral lomustine and lisaftoclax, subcutaneous or intravenous azacitidine or decitabine, and intravenous busulfan administered over specific days before transplantation. This single-arm, prospective study involves 30 patients who will be treated and monitored for their response to this conditioning approach. During the study, patients will be closely observed for survival rates without relapse and overall survival within one year post-transplant. Researchers will also track neutrophil and platelet recovery, transplant-related mortality, incidence and severity of graft-versus-host disease, and relapse rates within the first year. Assessments include clinical evaluations and laboratory tests to monitor organ function and treatment effects, with ongoing safety and efficacy monitoring throughout the study period.

A Single-arm, Prospective Study of a Clad-LABU Conditioning Regimen in HSCT for R/R MDS/AML in Elderly Patients