Age-Stratified Conditioning Regimen Efficacy for MDS Haplo-HSCT

NCT07677306 | Not Yet Recruiting Phase 2

• 1 other identifier: RTC Haplo-MDS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study plan aims to enroll adult patients diagnosed with myelodysplastic syndrome (MDS) who are scheduled to receive T-cell-replete haploidentical hematopoietic stem cell transplantation. After obtaining written informed consent, participants will receive either reduced-toxicity Bu/Flu/Cy/ATG conditioning regimen (for patients aged ≥55 years) or standard myeloablative modified Bu/Cy+ATG conditioning regimen (for patients aged \<55 years) followed by unified post-transplant immunosuppression and supportive care. The objective is to prospectively characterize the 1-year transplant-related mortality and comprehensively evaluate hematopoietic engraftment, graft-versus-host disease, infection, relapse, survival outcomes and conditioning-related organ toxicity among all enrolled patients undergoing haploidentical transplantation.

Conditions

Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

• transplant-related mortality (TRM)

  Death without disease progression or relapse

  Participants will be followed for an expected average of 1 years

Secondary Outcomes (7)

• Hematopoietic engraftment

  Day 30 and Day 90 post-transplantation

• Cumulative incidence of graft-versus-host disease (GVHD)

  Day 100 and 3 years after transplantation

• Cumulative incidence of CMV and EBV reactivation

  1 year after transplantation

• Cumulative incidence of hematologic relapse

  1 year after transplantation

• Disease-free survival (DFS)

  1 year after transplantation

Study Arms (1)

Age-Stratified Conditioning Regimen

OTHER

MDS patients without identical sibling donor or unrelated donor would receive haplo-HSCT. Participants will receive either reduced-toxicity Bu/Flu/Cy/ATG conditioning regimen (for patients aged ≥55 years) or standard myeloablative modified Bu/Cy+ATG conditioning regimen (for patients aged \<55 years) followed by unified post-transplant immunosuppression and supportive care.

Drug: RTC conditioning regimen and Modified Bu/Cy conditioning regimen

Interventions

RTC conditioning regimen and Modified Bu/Cy conditioning regimen DRUG

RTC preconditioning regimen consisted of cytarabine (2g/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/m2/day, days -6 to -2), semustine (250 mg/m2, day-3), and rabbit antithymocyte globulin (thymoglobulin, 2.5 mg/kg/d, days -5 to -2; Sanofi, France). Bu/Cy preconditioning regimen consisted of tandard institutional myeloablative busulfan + cyclophosphamide + rabbit ATG regimen per department routine dosing guidelines.

Age-Stratified Conditioning Regimen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital, Beijing Lu Daopei Hematology Hospital, Hebei Yanda Lu Daopei Hospital, Nanfang Hospital, Southern Medical University

Beijing, China

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Xiao-Jun Huang

  Peking University Institute of Hematology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Wang

CONTACT

8610-8832-6005; ywyw3172@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

CN (1)