- In children with hematological malignancies who received unrelated donor transplant chosen via high-resolution human leukocyte antigen (HLA)-typing, rabbit anti-T-lymphocyte globulin (ATLG) at 15 mg/kg deliver improved survival and non-relapse mortality (NRM) compared with at 30 mg/kg, without a significant increase in acute or chronic graft-versus-host disease (GVHD).
Why this matters
- 2 rabbit ATLG preparations are commonly used for GVHD prevention via serotherapy in hemopoietic stem-cell transplantation, which differs in potency, dosing, and efficacy.
- Phase 3 trial to compare intravenous ATLG 30 mg/kg (n=89) vs 15 mg/kg (n=91) in patients aged 0-18 y with hematological malignancies who received a transplant from an unrelated donor selected through high-resolution HLA typing.
- Funding: Fresenius, Neovii Biotech.
- 100-d cumulative incidence of grade II-IV acute GVHD: 36% with 15 mg/kg vs 29% with 30 mg/kg (P=.26).
- Cumulative incidence of chronic GVHD: 22% with 15 mg/kg vs 19% with 30 mg/kg (P=.69).
- Event-free survival: 77% with 15 mg/kg vs 61% with 30 mg/kg (P=.028).
- Cumulative incidence of NRM: 9% with 15 mg/kg vs 19% with 30 mg/kg (P=.092).
- 5-y probability of OS: 78% with 15 mg/kg vs 62% with 30 mg/kg (P=.045).
- Open-label study.