To comparing the efficacy of different durations of Maribavir treatment regimens in patients suffering from refractory CMV infection after allo-HSCT.
Hematopoietic stem cell transplantation (HSCT) represents the only potentially curative modality for hematologic malignancies. Nevertheless, post-transplant infections substantially elevate the risk of transplant-related mortality, with cytomegalovirus (CMV) infection being among the most prevalent complications. Although advances in prophylactic strategies and preemptive antiviral therapy have contributed to a measurable reduction in both the incidence of CMV infection and CMV disease, refractory or drug-resistant (R/R) CMV infection following HSCT remains a significant global therapeutic challenge. Recent epidemiologic data indicate that the incidence of drug-resistant CMV infection in HSCT recipients ranges from 1.7% to 14.5%, while that of refractory CMV infection falls between 29% and 39%. Notably, in China, the incidence of refractory CMV infection after HSCT is slightly higher than the global average-approximately 47% . Therefore, the investigator conduct a multicenter, randomized, controlled study based on retrospective research to further explore the efficacy of different durations of Maribavir treatment regimens in Allo-HSCT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
218
During the treatment period, maribavir is administered orally at a dosage of 400 mg twice daily. Participants will be stratified by clinical trial and received oral medication for varying durations.
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, China
RECRUITINGThe incidence of recurrent CMV infection
The incidence of recurrent CMV infection within 8 weeks after maribavir discontinuation
Time frame: The primary endpoint is assessed 8 weeks after maribavir discontinuation following allo-HSCT
The incidence of recurrent CMV infection
The incidence of recurrent CMV infection within 16 weeks after maribavir discontinuation
Time frame: The secondary endpoint is assessed 16 weeks after maribavir discontinuation following allo-HSCT
The incidence of recurrent CMV disease
The incidence of recurrent CMV disease within 8 weeks after maribavir discontinuation
Time frame: Follow-up is conducted for 8 weeks following maribavir discontinuation.
CMV resistance mutations
The incidence of CMV resistance mutations
Time frame: Through study completion. It is expected within one year post-transplant.
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