Comparing the Efficacy of Different Durations of Maribavir Treatment Regimens in Patients With Refractory Cytomegalovirus Infection Following Allo-HSCT: a Prospective, Multicenter, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- The incidence of recurrent CMV infection
研究概览
简要总结
To comparing the efficacy of different durations of Maribavir treatment regimens in patients suffering from refractory CMV infection after allo-HSCT.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First allogeneic hematopoietic stem cell transplantation;
- •Age ≥ 18 years;
- •Confirmed refractory CMV infection;
- •Refractory CMV infection is defined as fulfillment of any one of the following criteria:
- •Persistent or increasing CMV viremia despite ≥2 weeks of appropriate antiviral therapy-specifically, CMV DNA levels remain unchanged (i.e., change ≤ log₁₀) or increase (i.e., change > log₁₀)-concomitant with lack of clinical improvement or ongoing disease progression;
- •Drug-resistant CMV infection-defined as detection of specific CMV gene mutations associated with reduced susceptibility to one or more anti-CMV agents, in patients who otherwise meet the criteria for refractory CMV infection;
- •Intolerance to anti-CMV therapy-defined as inability to continue antiviral treatment due to severe adverse effects, such as clinically significant bone marrow suppression or renal impairment;
- •Provision of written informed consent and willingness to participate in this clinical study.
排除标准
- •Known allergic constitution, particularly hypersensitivity to any component of maribavir;
- •Active hepatitis B infection, defined as HBV DNA level ≥ 1 × 10³ IU/mL;
- •Confirmed HIV infection;
- •Severe impairment of major organ function, including but not limited to respiratory failure, cardiac failure, decompensated hepatic insufficiency, or renal insufficiency;
- •Central nervous system CMV infection;
- •History of substance use disorder or chronic alcoholism that may compromise the validity or interpretation of trial outcomes;
- •Presence of a psychiatric disorder or cognitive impairment precluding the provision of informed consent;
- •Any other condition deemed by the investigator to render the participant unsuitable for enrollment in this clinical trial.
研究组 & 干预措施
PCR-guided group
The experimental group discontinued maribavir after achieving two consecutive negative CMV-DNA PCR test, with a one-week interval, following drug administration.
干预措施: Maribavir (Drug)
Fixed-duration group
The fixed-duration group that discontinued maribavir treatment after 8 weeks.
干预措施: Maribavir (Drug)
结局指标
主要结局
The incidence of recurrent CMV infection
时间窗: The primary endpoint is assessed 8 weeks after maribavir discontinuation following allo-HSCT
The incidence of recurrent CMV infection within 8 weeks after maribavir discontinuation
次要结局
- The incidence of recurrent CMV infection(The secondary endpoint is assessed 16 weeks after maribavir discontinuation following allo-HSCT)
- The incidence of recurrent CMV disease(Follow-up is conducted for 8 weeks following maribavir discontinuation.)
- CMV resistance mutations(Through study completion. It is expected within one year post-transplant.)