Comparing the Efficacy of Different Durations of Maribavir Treatment Regimens in Allo-HSCT

Официальное название

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

Обзор

To comparing the efficacy of different durations of Maribavir treatment regimens in patients suffering from refractory CMV infection after allo-HSCT.

Подробное описание

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.

Вмешательства

• Препарат Maribavir
  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.

Первичные конечные точки

• The incidence of recurrent CMV infection [Срок оценки: The primary endpoint is assessed 8 weeks after maribavir discontinuation following allo-HSCT]

Вторичные конечные точки (3)

• The incidence of recurrent CMV infection [Срок оценки: The secondary endpoint is assessed 16 weeks after maribavir discontinuation following allo-HSCT]
• The incidence of recurrent CMV disease [Срок оценки: Follow-up is conducted for 8 weeks following maribavir discontinuation.]
• CMV resistance mutations [Срок оценки: Through study completion. It is expected within one year post-transplant.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Ruijin Hospital, Shanghai JiaoTong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT07511127 · RJBMT-2026CMV

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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