Status:

RECRUITING

Reduced ATG Plus Mini PTCy for GVHD Prophylaxis in Haplo-SCT

Lead Sponsor:

Peking University People's Hospital

Conditions:

Myelodysplastic Syndrome

Acute Leukemia

Eligibility:

All Genders

12-65 years

Phase:

PHASE2

Brief Summary

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is regarded as a curative therapy for a variety of hematological malignancies and nonmalignant diseases. However, donor limitations have ...

Eligibility Criteria

Inclusion

  • Patients with AL - CR and/or myelodysplastic syndromes undergoing allogeneic hematopoietic stem cell transplantation for the first time;
  • No gender limit, aged 12 - 65 years;
  • Planned haploidentical donor transplantation, excluding transplantation from maternal and collateral donors;
  • Eastern Cooperative Oncology Group (ECOG) performance status score≤3 points;
  • Baseline organ function tests meet the following criteria:
  • (1) Left ventricular ejection fraction (LVEF) \> 55%; (2) Serum creatinine ≤ 1.5 × upper limit of normal (ULN).

Exclusion

  • Patients with severe dysfunction of brain, heart, kidney or liver;
  • Those in refractory malignant status;
  • Patients with other malignancies requiring treatment;
  • Presence of uncontrolled severe active infection clinically;
  • Expected survival period of less than 3 months;
  • History of severe allergic reactions;
  • Pregnant or breastfeeding women; (8)Presence of any condition deemed by the investigator as unsuitable for study enrollment.

Key Trial Info

Start Date :

May 21 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 31 2026

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT06984536

Start Date

May 21 2025

End Date

July 31 2026

Last Update

July 25 2025

Active Locations (1)

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1

Peking University People'S Hospital

Beijing, China