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

Who is this study for? Elderly or high comorbidity burden patients receiving haploidentical hematopoietic stem cell transplantation
What treatments are being studied? Cytarabine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Patients older than 55 years or those with HCT-CI scores of ≥3, without ISD nor URD, receiving haplo-HSCT

Locations
Other Locations
China
Peking University, Institute of Hematolgoy
RECRUITING
Beijing
Contact Information
Primary
Xiao-Dong Mo, MD
mxd453@163.com
8610-8832-6001
Backup
Xiao-Dong Mo
mxd453@163.com
8610-8832-4577
Time Frame
Start Date: 2018-02-01
Estimated Completion Date: 2025-09-01
Participants
Target number of participants: 50
Treatments
Experimental: RIC regimen
Old patients or those have high comorbidity burden without identical sibling donor or unrelated donor would receive RIC haplo-HSCT.~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).
Sponsors
Leads: Peking University People's Hospital

This content was sourced from clinicaltrials.gov

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