Short versus long maribavir treatment after allogeneic stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, multicenter randomized controlled trial compares different durations of maribavir therapy in adults who develop refractory or drug‑resistant CMV following a first allogeneic hematopoietic stem cell transplant. Participants will be randomized to prespecified maribavir treatment lengths and followed for virologic clearance, clinical response, and safety outcomes. The protocol is informed by retrospective data suggesting treatment duration may affect outcomes and uses standardized CMV DNA monitoring and clinical assessments. The lead site is Ruijin Hospital, Shanghai JiaoTong University School of Medicine.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. First allogeneic hematopoietic stem cell transplantation;
2. Age ≥ 18 years;
3. 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;
4. Provision of written informed consent and willingness to participate in this clinical study.

Exclusion Criteria:

1. Known allergic constitution, particularly hypersensitivity to any component of maribavir;
2. Active hepatitis B infection, defined as HBV DNA level ≥ 1 × 10³ IU/mL;
3. Confirmed HIV infection;
4. Severe impairment of major organ function, including but not limited to respiratory failure, cardiac failure, decompensated hepatic insufficiency, or renal insufficiency;
5. Central nervous system CMV infection;
6. History of substance use disorder or chronic alcoholism that may compromise the validity or interpretation of trial outcomes;
7. Presence of a psychiatric disorder or cognitive impairment precluding the provision of informed consent;
8. Any other condition deemed by the investigator to render the participant unsuitable for enrollment in this clinical trial.

Where it's running

• Ruijin Hospital, Shanghai JiaoTong University School of Medicine
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Xiaoxia Hu
• Email: hxx12276@rjh.com.cn
• Phone: +86-021-64370045

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.