Age-Stratified Conditioning Regimen Efficacy for MDS Haplo-HSCT

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• Myelodysplastic Syndromes 2,124

Study arms

• Other
  Age-Stratified Conditioning Regimen

  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

• DrugRTC 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 guidelines.

Primary outcomes

1. transplant-related mortality (TRM)

   Death without disease progression or relapse

   Time frame: Participants will be followed for an expected average of 1 years

Secondary outcomes

1. Hematopoietic engraftment

   Neutrophil engraftment is defined as the first day of sustained absolute neutrophil count (ANC) ≥0.5×10⁹/L for 3 consecutive days; platelet engraftment is defined as the first day of sustained platelet count (PLT) ≥20×10⁹/L without transfusion support for 7 consecutive days. Cumulative incidence of neutrophil engraftment at Day 30 and platelet engraftment at Day 90 will be calculated.

   Time frame: Day 30 and Day 90 post-transplantation

2. Cumulative incidence of graft-versus-host disease (GVHD)

   Cumulative incidence of Grade II-IV and Grade III-IV acute GVHD at Day 100, as well as chronic GVHD and moderate-severe chronic GVHD within 3 years after transplantation, graded per Seattle criteria.

   Time frame: Day 100 and 3 years after transplantation

3. Cumulative incidence of CMV and EBV reactivation

   Defined as any detectable CMV or EBV viral load elevation requiring clinical intervention within 1 year after transplantation.

   Time frame: 1 year after transplantation

4. Cumulative incidence of hematologic relapse

   Defined as bone marrow blast recurrence or extramedullary disease relapse within 1 year after transplantation.

   Time frame: 1 year after transplantation

5. Disease-free survival (DFS)

   Defined as the time from transplantation until hematologic relapse or death from any cause.

   Time frame: 1 year after transplantation

6. Overall survival（OS）

   Defined as the time from treatment until death from any cause or the last follow-up.

   Time frame: 1 year after transplantation

7. Conditioning-related organ toxicities

   Incidence of grade 1-4 cardiac, renal, hepatic, gastrointestinal and oral mucosal toxicities from conditioning initiation to Day +30 post-transplantation, with separate analysis of Grade 3-4 severe organ injury, hepatic veno-occlusive disease (VOD), and conditioning-related death, graded per WHO organ toxicity scale.

   Time frame: From conditioning start to Day 30 post-transplantation

Individual participant data

Plan to share: Undecided