Clinical trial · Interventional
ATG Plus Low-dose PT-Cy for GVHD Prevention
Randomized Trial of Anti-thymocyte Globulin Plus Low-dose Post-transplant Cyclophosphamide for GVHD Prevention in Haploidentical Donor HCT
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): DSMB recommended halting the study owing to futility after the first interim analysis in August 2024.
Summary
Brief summary (as posted)
During the past decades, the wider application of easily available haploidentical donor hematopoietic cell transplant (haplo-HCT) has been made possible through the T cell-replete (TCR) regimens including T cell regulation with anti-thymocyte globulin (ATG)/granulocyte colony-stimulating factor (GCSF) and post-transplant cyclophosphamide (PTCy). To achieve decreased non-relapse mortality (NRM) and improved long-term outcomes in haploidentical transplant, the joint use of ATG and PTCy might effectively reduce graft versus host disease (GVHD) and mortality associated with severe forms of GVHD. Recently, investigators established a regimen using low-dose PTCy in conjunction with standard-dose ATG in order to lower the risk of GVHD without compromising engraftment and disease relapse.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ATG | Drug | — | UNRESOLVED |
| Cyclophosphamid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ATG-PTCy cohort
- description
- The conditioning regimen is ATG/G-CSF based protocol (the so-called Beijing protocol). The rabbit ATG (Sangstat-Genzyme) 2.5mg/kg/day i.v., on days from - 5 to - 2 were administered.Two doses of 14.5 mg/kg Cy were given on days 3 and 4 post-HCT in ATG-PTCy cohort.
- interventionNames
- Drug: Cyclophosphamid
- Drug: ATG
- type
- ACTIVE_COMPARATOR
- label
- ATG cohort
- description
- The conditioning regimen is ATG/G-CSF based protocol (the so-called Beijing protocol). The rabbit ATG (Sangstat-Genzyme) 2.5mg/kg/day i.v., on days from - 5 to - 2 were administered.
- interventionNames
- Drug: ATG
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with acute leukemia and/or myelodysplastic syndrome undergoing their first allogeneic hematopoietic stem cell transplantation; 2. Male or female , aged 12-55 years; 3. Haploidentical donor transplantation; 4. ECOG score ≤3; The basic organ function tests met the following standards; 1\) Cardiac ejection index \>55% 2) Creatinine ≤1.5 times the highest normal value (ULN) Exclusion Criteria: 1. Severe brain, heart, kidney or liver dysfunction; 2. Refractory malignant state; 3. Patients with other malignant tumors requiring treatment; 4. Clinically uncontrolled severe active infection; 5. The expected survival time was less than 3 months. 6. A history of severe anaphylaxis. 7. Pregnant or lactating women; 8. Any condition considered by the investigators to be unsuitable for enrollment.
References
Publications (1)
- DERIVEDXu ZL, Han TT, Zhu XL, Liu J, Lv M, Sun YQ, Mo XD, Cheng YF, Xu LP, Zhang XH, Huang XJ, Wang Y. Randomized trial of anti-thymocyte globulin plus lowdose post-transplant cyclophosphamide to prevent graft-versus- host disease in haploidentical transplantation. Haematologica. 2025 Dec 1;110(12):2965-2973. doi: 10.3324/haematol.2025.287504. Epub 2025 Jun 19. PMID 40534493