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

NCT ID: NCT06984536

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-21
• Study Completion Date: 2026-07-31

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.

Conditions

Myelodysplastic Syndrome; Acute Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Reduced ATG puls mini PTCy

Patients recieved ATG 7.5mg/kg plus PTCy 14.5mg/kg on day +3 and +4 for GVHD prophylaxis in haplo-SCT

Group Type: EXPERIMENTAL

Reduced ATG plus mini PTCy

Intervention Type: DRUG

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.

Interventions

Reduced 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiao-Jun Huang

Peking University People's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University People'S Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yu Wang, M.D.

Role: CONTACT

ywyw3172@sina.com

86-010-8832-6000

Facility Contacts

yu wang

Role: primary

ywyw3172@sina.com

861088326000

Other Identifiers

Lower ATG plus miniPTCy

Identifier Type: -

Identifier Source: org_study_id