The application of rituximab during the conditioning regimen prevents Epstein - Barr virus infection following rATG-based haploidentical hematopoietic stem cell transplantation in the era of letermovir for cytomegalovirus prophylaxis.
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BACKGROUND: In the era of letermovir for cytomegalovirus (CMV) prophylaxis, several centers reported that the incidence of Epstein-Barr virus (EBV) infection were significantly increased. OBJECTIVE: To investigate the efficacy and safety of rituximab administration during conditioning regimen following haploidentical hematopoietic stem cell transplantation(haplo-HSCT)in the prevention of post-transplant EBV infection. METHODS: We conducted a retrospective analysis of 100 patients with acute leukemia or myelodysplastic syndrome who underwent haplo-HSCT. Patients in observation group(R group) received rituximab (375 mg/m²) on day -3 before transplantation due to the presence of donor-specific antibody (MFI ≥ 2000) (n = 25) and patients in control group (C group) did not receive rituximab (n = 75) and donor-specific antibody was low (MFI < 2000). The primary objectives were the incidence of EBV-DNA viremia and PTLD within one-year post-transplantation. Secondary objectives included the incidence of CMV infection, cumulative incidence of acute graft-versus-host disease (aGVHD) and chronic GVHD, 100-day non-relapse mortality (NRM), progression-free survival (PFS), and overall survival (OS). RESULTS: No significant differences were observed in baseline characteristics between the two groups except for primary disease. When compared with the C group, patients in R group exhibited a lower cumulative incidence of EBV viremia within one-year post - transplantation (4.00% vs. 22.67%, P = 0.049) and a lower incidence of aGVHD (28% vs. 50.67%, P = 0.048). There was a trend toward reduction of PTLD in the R group compared with C group (0% vs. 10.67%, P = 0.089).There were no significant differences of the incidence of CMV viremia (24% vs. 13.33%, P = 0.208), cGVHD (16% vs. 12%, P = 0.607), and 100 - day NRM (4.0% vs. 10.67%, P = 0.313) between two groups. The 2-year OS rates in the R group and C group were 83.8% ± 0.086% and 81.9% ± 0.050% respectively (P = 0.360). The 2-year PFS rates in the R group and C group were 83.8% ± 0.086% and 72.6% ± 0.068% respectively (P = 0.360). CONCLUSION: The combined use of rituximab during the conditioning regimen may be regarded as an effective strategy for preventing EBV reactivation after rATG - based haplo - HSCT in the era of letermovir for CMV prophylaxis.Prospective randomized controlled trials are still required to further validate the reliability of the results.