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

Phase 2

Not yet recruiting

• Conditions: Myelodysplastic Syndrome; Acute Leukemia
• Interventions: Drug: Reduced ATG plus mini PTCy

• Registration Number: NCT06984536
• Lead Sponsor: Peking University People's Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-03
• Study First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Study Start: 2025-05-22
• Study First Posted: 2025-05-22
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients with AL - CR and/or myelodysplastic syndromes undergoing allogeneic hematopoietic stem cell transplantation for the first time;
2. No gender limit, aged 12 - 65 years;
3. Planned haploidentical donor transplantation, excluding transplantation from maternal and collateral donors;
4. Eastern Cooperative Oncology Group (ECOG) performance status score≤3 points;
5. 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 Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reduced ATG puls mini PTCy	Reduced ATG plus mini PTCy	Patients recieved ATG 7.5mg/kg plus PTCy 14.5mg/kg on day +3 and +4 for GVHD prophylaxis in haplo-SCT

Primary Outcome Measures

Name	Time	Method
Non-relapse mortality	100 days	None-relapse mortality within 100 days post transplantation

Secondary Outcome Measures

Name	Time	Method
Regimen related toxicity	30 days post transplantation	Regimen related toxicity will be evaluated by Bearman Criteria from the begining of conditioning to 1 month post HSCT. The organ functions that need to be assessed include the heart, liver, kidneys, cystitis, oral mucositis, and the gastrointestinal tract.
Engraftment	Within 30 days post transplant. Myeloid engraftment was defined as the first of three consecutive days with an ANC 0.5×109 /L, and platelet engraftment was defined as the day the platelet count met or exceeded 20×10^9 /L without transfusion for a week.	Myeloid and platelet engraftment
Disease relapse	1 year post transplantation	The incidence of disease relapse
Disease free survival	1 year post transplantation	The time from the start of transplantation until a patient experiences leukemia relapse or death from any cause, whichever occurs first.

Trial Locations

Locations (1)

Peking University People'S Hospital; 🇨🇳 Beijing, China