NCT03412409

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

Reduced Intensity Conditioning Regimen for Elderly or High Comorbidity Burden Patients Receiving Haploidentical Hematopoietic Stem Cell Transplantation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

RIC regimen was given for elderly patients or those with high comorbidity burden who would receive haplo-HSCT. The elderly patients were defined as older than 55 years. The burden of comorbidities in HSCT recipients was assessed based on the hematopoietic cell transplantation-specific comorbidity index (HCT-CI), and patients with score ≥3 were assigned as high burden. The primary end point was transplant-related mortality, and the secondary endpoints included overall survival, disease-free survival, relapse, engraftment, graft-versus-host disease (GVHD), and infections. Following time is 1 years.

Conditions

• Acute Leukemia
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Cytarabine	RIC preconditioning regimen consisted of cytarabine (2 g/m2/day, days -10 to -9), busulfan (3.2 mg/kg/day on days -8 to -6), cyclophosphamide (1.0 g/m2/day, days -5 to -4), fludarabine (30 mg/m-2/day, days -6 to -2), semustine (250 mg/m-2, day -3), and rabbit antithymocyte globulin (thymoglobulin, 2.5 mg/kg/d, days -5 to -2; Sanofi, France).

Timeline

• Start date: 2018-02-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2018-01-26
• Last updated: 2024-03-26

Locations

1 site across 1 country: China