Phase II Trial of Maribavir for CMV in Patients With Lymphoid Malignancy on Bispecific Antibodies

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital

About this trial

This is an open-label, single arm, multicenter study to evaluate the feasibility of maribavir treatment in multiple myeloma and lymphoma patients undergoing bispecific antibody treatment and experiencing treatment emergent CMV events

Eligibility criteria

Qualifiers

Subject is ≥19 years of age at the time of signing the informed consent form (ICF).

Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures.

ECOG performance status of 0, 1, or 2. ⑦ Individual of childbearing potential (IOCBP) must: A. Have two negative pregnancy tests before study treatment, and agree to ongoing testing.

Disqualifiers

Requires ganciclovir, valganciclovir, foscarnet, or cidofovir for non-CMV indications or requires co-administration with maribavir.

Known hypersensitivity to maribavir. ③ CMV disease involving the CNS (retinitis alone is allowed). ④ Received allogeneic SCT within 1 year or autologous SCT within 12 weeks prior to study treatment.

Males: CrCl = (140 - age) × weight (kg) / (72 × creatinine [mg/dL])

Females: Multiply above result by 0.85 B. AST or ALT >5 × ULN C. Total bilirubin >3 × ULN (except Gilbert's syndrome)

Trial design

Treatments tested in this trial

  • Maribavir

Treatment groups

20 Participants
are divided into 1 treatment group