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Not yet recruiting NCT07677306

Age-Stratified Conditioning Regimen Efficacy for MDS Haplo-HSCT

Phase II Interventional Myelodysplastic Syndromes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RTC conditioning regimen and Modified Bu/Cy conditioning regimen.
Who it may be relevant to
Registry conditions: Myelodysplastic Syndromes. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Prospective Cohort Study of Age-Stratified Busulfan-Based Conditioning Regimens in Adult Patients With Myelodysplastic Syndrome Receiving Haploidentical Hematopoietic Stem Cell Transplantation

Overview

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.

Interventions

  • Drug RTC conditioning regimen and Modified Bu/Cy conditioning regimen
    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 gu

Primary outcome measures

  • transplant-related mortality (TRM) [Time frame: Participants will be followed for an expected average of 1 years]
Secondary outcome measures (7)
  • Hematopoietic engraftment [Time frame: Day 30 and Day 90 post-transplantation]
  • Cumulative incidence of graft-versus-host disease (GVHD) [Time frame: Day 100 and 3 years after transplantation]
  • Cumulative incidence of CMV and EBV reactivation [Time frame: 1 year after transplantation]
  • Cumulative incidence of hematologic relapse [Time frame: 1 year after transplantation]
  • Disease-free survival (DFS) [Time frame: 1 year after transplantation]
  • Overall survival（OS） [Time frame: 1 year after transplantation]
  • Conditioning-related organ toxicities [Time frame: From conditioning start to Day 30 post-transplantation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University People's Hospital, Beijing Lu Daopei Hematology Hospital, Hebei Yanda Lu — Beijing

Identifiers

NCT: NCT07677306 · RTC Haplo-MDS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗