drugset / Trial / NCT03412409

RIC Regimen for Elderly or High Comorbidity Burden Patients Receiving Haplo-HSCT

NCT03412409

Phase 2 Unknown 50 enrolled Peking University People's Hospital
NaSingle-groupOpen-labelTreatment

Summary

This study aimed to evaluate the efficacy of reduced intensity conditioning (RIC) regimen in elderly or high comorbidity burden patients who receive haploidentical hematopoietic stem cell transplantation (haplo-HSCT). Haplo-HSCT is an effective treatment option for patients who did not have identical sibling donor (ISD) or unrelated donor (URD). However, post-transplant transplant-related mortality (TRM) is one of the major causes for transplant failure, and the risk of TRM for old patients or those with high comorbidity burden was higher. RIC regimen may decrease the risk of TRM for haplo-HSCT recipients. The study hypothesis: Using RIC haplo-HSCT regimen in elderly patients or those with high comorbidity burden can reduce TRM and improve survival.

Timeline

Start
2018-02-01
Primary completion
2025-09-01
Completion
2025-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic 2.5 mg/kg
Subject Busulfan Small molecule 3.2 mg/kg Intravenous
Subject Cyclophosphamide Other / unclassified 1000 mg/m2 Intravenous
Subject Cytarabine Small molecule 2000 mg/m2 Intravenous
Subject Fludarabine Small molecule 30 mg/m2 Intravenous
Subject Semustine Small molecule 250 mg/m2 Oral