Actively Recruiting
Phase II Trial of Maribavir for CMV in Patients With Lymphoid Malignancy on Bispecific Antibodies
Led by Seoul National University Hospital · Updated on 2025-12-04
20
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Phase II Trial of Maribavir for CMV in Patients With Lymphoid Malignancy on Bispecific Antibodies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older at time of informed consent
- Able and willing to voluntarily sign informed consent form
- Willing and able to follow study visit schedule and protocol requirements
- Diagnosed with multiple myeloma, follicular lymphoma, or large B-cell lymphoma (including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, transformed follicular lymphoma, or transformed marginal zone lymphoma)
- Receiving one of the specified bispecific antibodies for multiple myeloma or lymphoma
- Documented clinically significant CMV infection defined as onset of CMV end-organ disease or initiation of anti-CMV pre-emptive therapy based on two consecutive CMV viremia assessments of 500 IU/mL or higher
- ECOG performance status of 0, 1, or 2
- For individuals of childbearing potential: two negative pregnancy tests before treatment and agreement to ongoing testing
- Individuals of childbearing potential must commit to abstinence or use two forms of contraception (one highly effective plus one barrier method) starting 28 days before treatment, during treatment, and for 90 days after last dose
- Male subjects must practice abstinence or use condoms with partners who are pregnant or of childbearing potential during treatment and for 90 days after last dose
- Male subjects must not donate sperm during treatment and for 90 days after last dose
- Female subjects must not donate eggs during treatment and for 90 days after last dose
You will not qualify if you...
- Need for ganciclovir, valganciclovir, foscarnet, or cidofovir for non-CMV reasons or requiring co-administration with maribavir
- Known hypersensitivity to maribavir
- CMV disease involving the central nervous system (retinitis alone is allowed)
- Received allogeneic stem cell transplant within 1 year or autologous stem cell transplant within 12 weeks before treatment; allogeneic recipients must not have active graft-versus-host disease
- Any significant medical condition, infection, lab abnormality, or psychiatric illness posing unacceptable risk
- Any condition that may interfere with data interpretation
- Laboratory abnormalities including creatinine clearance below 10 mL/min or requiring dialysis, AST or ALT greater than 5 times upper limit of normal, total bilirubin greater than 3 times upper limit of normal (except Gilbert's syndrome)
- Gastrointestinal disease or surgery affecting maribavir absorption
- Severe vomiting, diarrhea, or gastrointestinal illness within 24 hours before first dose
- Use of immunosuppressive medication within 14 days before treatment except certain corticosteroids and premedications
- Requires mechanical ventilation or vasopressors at enrollment
- Positive for HIV, active or chronic hepatitis B, active hepatitis A or C infections
- Pregnant, breastfeeding, or planning pregnancy during study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
Research Team
J
Ja Min Byun, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here