NCT06984536 Reduced ATG Plus Mini PTCy for GVHD Prophylaxis in Haplo-SCT
| NCT ID | NCT06984536 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking University People's Hospital |
| Condition | Myelodysplastic Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-05-21 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2025-05-21 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06984536 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 65 Years, studying Myelodysplastic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06984536 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06984536 currently recruiting?
Yes, NCT06984536 is actively recruiting participants. Contact the research team at ywyw3172@sina.com for enrollment information.
Where is the NCT06984536 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06984536 clinical trial?
NCT06984536 is sponsored by Peking University People's Hospital. The trial plans to enroll 40 participants.