ATG Plus Low-dose PT-Cy for GVHD Prevention

Summary

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.

Timeline

Start

2023-11-01

Primary completion

2024-12-31

Completion

2024-12-31

Outcome

Outcome not reported

Stopped: “DSMB recommended halting the study owing to futility after the first interim analysis in August 2024.”

Publications

• Xu 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.

Drugs

Indications