RecruitingPhase 2NCT06984536

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

Reduced-dose Anti-thymocyte Globulin Plus Mini-dose Post-transplant Cyclophosphamide for GVHD Prevention in Haploidentical Donor HCT for Hematologic Malignancy

Sponsor

Peking University People's Hospital

Enrollment

40 participants

Start Date

May 21, 2025

Study Type

INTERVENTIONAL

Conditions

Myelodysplastic Syndrome Acute Leukemia

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 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.

Eligibility

Min Age: 12 YearsMax Age: 65 Years

Inclusion Criteria6

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 Criteria7

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.

Interventions

DRUGReduced ATG plus mini PTCy

The conditioning protocol comprises cytarabine (Ara-C) (4 g/m2/day, days -9), busulfan (Bu) (3.2 mg/kg/day, days -8 to -6), cyclophosphamide (Cy) (1.8 g/m2/kg, days -5 and -4), simustine (250 mg/m2, day -3) and r-ATG (total 7.5mg/kg ,from days -5 to -2). Mini PTCy 14.5mg/kg/day will be given on day +3 and +4.