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

Sponsor
Ruijin Hospital
Study ID
NCT07511127
Phase
PHASE3
Status
Recruiting
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Conditions

  • Hematologic Malignancy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Maribavir — DRUG
    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.

Study Details

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

Key Dates

First listed
Apr 6, 2026
Start date
Feb 28, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
218 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Fixed-duration group
    The fixed-duration group that discontinued maribavir treatment after 8 weeks.
  • Experimental: 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.

Primary Outcome Measure

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

Central Contacts

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