Reduced Intensity Conditioning Regimen for Low- and Intermediate-risk Myelodysplastic Syndrome Patients Receiving Haploidentical Hematopoietic Stem Cell Transplantation

Who is this study for? Patients with low- and Intermediate-risk myelodysplastic syndrome receiving haploidentical hematopoietic stem cell transplantation
Status: Unknown
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 low- and intermediate-risk myelodysplastic syndrome (MDS) patients who receive haploidentical hematopoietic stem cell transplantation (haplo-HSCT). Haplo-HSCT is an effective treatment option for MDS 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 in MDS patients, and the risk of TRM for haplo-HSCT recipients was higher than that of ISD recipients. RIC regimen can decrease the risk of TRM for haplo-HSCT recipients; however, the risk for relapse may increase in these patients. Thus, RIC regimen may be more appropriate for low- and intermediate-risk MDS patients receiving haplo-HSCT. The study hypothesis: Using RIC haplo-HSCT regimen in patients with low- and risk MDS can reduce TRM and improve survival.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 70
Healthy Volunteers: f
View:

• Patients who had low- and intermediate-risk MDS without ISD nor URD receiving haploidentical hematopoietic stem cell transplantation

Locations
Other Locations
China
Peking University Institute of Hematology,Beijing
RECRUITING
Beijing
Contact Information
Primary
Xiao-Dong Mo
mxd453@163.com
8610-8832-6001
Backup
Xiao-Dong Mo
8610-8832-4577
Time Frame
Start Date: 2018-02-01
Completion Date: 2023-03-01
Participants
Target number of participants: 50
Treatments
Other: RIC regimen
Low- and intermediate MDS patients 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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