Lower-dose ATG and cyclophosphamide to prevent graft-versus-host disease in haploidentical transplant
Tests two reduced-dose drugs after transplant in people with leukemia or myelodysplastic syndrome.
Plain-language title generated from the registry record
Registry title: Reduced ATG Plus Mini PTCy for GVHD Prophylaxis in Haplo-SCT
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 12 to 65 with acute leukemia in complete remission or myelodysplastic syndromes, who are having a first stem cell transplant from a half-matched family donor.
- Age
- 12 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Acute leukemia in complete remission (CR) and/or myelodysplastic syndromes; first allogeneic stem cell transplant from a haploidentical donor (not a maternal or collateral donor).
- Earlier treatment
- No earlier allogeneic stem cell transplant (this must be the first one).
- Biomarker or test result
- Left ventricular ejection fraction (LVEF) above 55%; serum creatinine up to 1.5 × the upper limit of normal (ULN).
Main reasons for not taking part
- Severe problems with the brain, heart, kidney or liver
- Disease that does not respond to treatment
- Another cancer that needs treatment
- Severe active infection that is not under control
- Expected survival of less than 3 months
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 65 years old?
Source: NCT06984536, who can take part
Where in China
- Peking University People's HospitalBeijing, ChinaContact: yu wangTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Peking University People's Hospital
- Trial code
- NCT06984536
- Record updated
- 25 July 2025
- Original description
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.Read full original descriptionShow less
Reduced-dose Anti-thymocyte Globulin Plus Mini-dose Post-transplant Cyclophosphamide for GVHD Prevention in Haploidentical Donor HCT for Hematologic Malignancy
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.
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; History of severe allergic reactions; Pregnant or breastfeeding women; (8)Presence of any condition deemed by the investigator as unsuitable for study enrollment; Expected survival period of less than 3 months.