Actively Recruiting

Phase 2
Age: 12Years - 65Years
All Genders
NCT06984536

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

Led by Peking University People's Hospital · Updated on 2025-07-25

40

Participants Needed

1

Research Sites

62 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 restricted the widespread use of allo-HSCT for a long period. The development and success of haploidentical allografts worldwide makes "everyone has a donor" a reality. In the past two decades, researchers have established several haploidentical HSCT (haplo-HSCT) protocols based on different approaches to induce immune tolerance. The representative approaches for haplo-HSCT without in vitro. T cell depletion include granulocyte colony-stimulating factor (G-CSF) plus Anti-human Thymocyte Immunoglobulin (ATG) based (Beijing Protocol) and post-transplantation cyclophosphamide based (PT-Cy, Baltimore Protocol) protocols. Both of two protocols have common problems that need to be solved, including infection transplantation related mortality and disease relapse. The main aim of this study is to explore whether the combined protocol can improve the efficacy of haploidentical transplantation further.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with acute leukemia in complete remission and/or myelodysplastic syndromes undergoing their first allogeneic hematopoietic stem cell transplantation
  • No gender limit, aged 12 to 65 years
  • Planned haploidentical donor transplantation excluding maternal and collateral donors
  • Eastern Cooperative Oncology Group (ECOG) performance status score 3 or less
  • Baseline organ function: left ventricular ejection fraction greater than 55%, serum creatinine less than or equal to 1.5 times the upper limit of normal
Not Eligible

You will not qualify if you...

  • Severe dysfunction of brain, heart, kidney, or liver
  • Refractory malignant status
  • Other malignancies requiring treatment
  • Uncontrolled severe active infection
  • Expected survival less than 3 months
  • History of severe allergic reactions
  • Pregnant or breastfeeding women
  • Any condition deemed unsuitable for study enrollment by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking University People'S Hospital

Beijing, China

Actively Recruiting

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Research Team

Y

Yu Wang, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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