Abstract
The optimal rabbit anti-thymocyte globulin (rATG) graft-versus-host disease (GVHD) prophylaxis regimen in matched sibling donor peripheral blood stem cell transplantation (MSD-PBSCT) remains to be elucidated. In this prospective study, we used low-dose rATG for GVHD prophylaxis in patients or donors aged ≥ 40 years with hematological malignancies receiving MSD-PBSCT. rATG was administered to 40 patients at an intravenous dose of 5 mg/kg divided over day 5 and day 4 before graft infusion. No graft failure occurred. Median times to leukocyte engraftment and platelet engraftment were 11.0 days and 13.9 days. The cumulative incidence of grades 2–4 and grades 3–4 acute GVHD at day +100 was 30.0% and 2.6%. The 2-year cumulative incidence of extensive chronic GVHD and severe chronic GVHD was 11.4% and 14.7%. 93.5% (29/31) of patients had discontinued immunosuppressive medication within 3 years after transplantation. The 2-year cumulative incidence of transplant-related mortality (TRM) and relapse was 14.0% and 22.6%. The cumulative incidence of cytomegalovirus reactivation, Epstein–Barr virus reactivation, and fungal infection was 22.3%, 12.9%, and 12.5%. Kaplan–Meier estimates for overall survival, disease-free survival, and GVHD-free and relapse-free survival 3 years after transplantation were 68.9%, 68.9%, and 54.0%. rATG for GVHD prophylaxis is tolerable and efficacious at a 5 mg/kg total dose administered over 2 days (days −5 to −4) in patients receiving allogeneic MSD-PBSCT.
Highlights
Chronic graft-versus-host disease (GVHD) increases the risk for long-term morbidity, poor quality of life, and death after matched sibling donor (MSD) stem cell transplantation [1]
In this prospective study (ClinicalTrials.gov Identifier: NCT02677181), we investigated the feasibility of using low-dose rabbit anti-thymocyte globulin (rATG) (Sanofi, Paris, France: preparation containing polyclonal immunoglobulins obtained from hyperimmune sera of rabbits immunized with human thymocytes) for GVHD prophylaxis in patients or donors aged ≥ 40 years with hematological malignancies receiving MSD-PBSCT, compared with no use of rATG in patients or donors aged 14 to 40 years. rATG was administered at an intravenous dose of 5 mg/kg divided over day 5 and day 4 before graft infusion, which is half of the dose used by our group to reduce the risk of severe acute GVHD (aGVHD) in patients receiving hematopoietic stem cell transplantation without ex vivo T cell depletion from haploidentical donors [8]
*P value ATG, anti-thymocyte globulin; 95% CI, cumulative incidence 95% CI; DFS, disease-free survival; GVHD, graft-versus-host disease; OS, overall survival
Summary
Chronic graft-versus-host disease (GVHD) increases the risk for long-term morbidity, poor quality of life, and death after matched sibling donor (MSD) stem cell transplantation [1]. Due to a high incidence of cGVHD in patients or donors aged ≥ 40 years, rATG was prospectively added to the preparative regimen in MSDPBSCT. In this prospective study (ClinicalTrials.gov Identifier: NCT02677181), we investigated the feasibility of using low-dose rATG (Sanofi, Paris, France: preparation containing polyclonal immunoglobulins obtained from hyperimmune sera of rabbits immunized with human thymocytes) for GVHD prophylaxis in patients or donors aged ≥ 40 years with hematological malignancies receiving MSD-PBSCT, compared with no use of rATG in patients or donors aged 14 to 40 years.
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