RIC Regimen for Low- and Intermediate-risk MDS Receiving Haplo-HSCT

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03412266

Enrollment

Registered

2018-01-26

Start date

2018-02-01

Completion date

2023-03-01

Last updated

2022-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndromes

Keywords

RIC regimen; MDS; haplo-HSCT; survival

Brief 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.

Detailed description

RIC regimen was given for low and intermediate MDS patients who would receive haplo-HSCT. The primary end point was transplant-related mortality. The secondary end points were overall survival, disease-free survival, relapse, , graft-versus-host disease (GVHD), and infections. Following time is 1 years.

Interventions

DRUGCytarabine

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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 70 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Patients having ISD or URD; patients having high-risk MDS; patients with active infection; patients with poor compliance; patients with organ failure

Design outcomes

Primary

Measure	Time frame	Description
Transplant-related mortality	Participants will be followed for an expected average of 1 years	Death without disease progression or relapse

Countries

China

Contacts

Primary ContactXiao-Dong Mo

mxd453@163.com8610-8832-6001

Backup ContactXiao-Dong Mo

8610-8832-4577

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026