Actively Recruiting
Maribavir Treatment of Cytomegalovirus for Lymphoid Malignancy Patients Undergoing Bispecific Antibodies
Led by Seoul National University Hospital · Updated on 2025-12-04
20
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of maribavir in patients with multiple myeloma or lymphoma who develop cytomegalovirus (CMV) reactivation during treatment with bispecific antibodies (BsAbs). BsAbs are increasingly used due to their effectiveness but carry a high risk of infections like CMV, especially in patients who have had extensive prior treatments and weakened immune systems. Maribavir is an oral antiviral drug with a new mechanism and a favorable safety profile, offering a potential alternative to existing CMV treatments that may have limitations due to toxicity or accessibility. Participants will receive maribavir at a dose of 400 mg twice daily starting from Week 1 and continuing until CMV clearance. CMV clearance is defined as either an unquantifiable plasma CMV DNA level or a plasma CMV DNA level below 500 IU/mL without evidence of CMV disease. This is a single-arm, open-label study involving patients diagnosed with multiple myeloma, follicular lymphoma, or large B-cell lymphomas who are receiving bispecific antibody therapy and have documented clinically significant CMV infection. During the study, participants will be monitored from screening until Week 18 for safety and CMV DNA titer reduction. Researchers will measure how quickly and effectively the CMV DNA level drops below 500 IU/mL and track any safety outcomes during treatment. The study also evaluates the rate and timing of a significant reduction in CMV DNA and the occurrence of breakthrough CMV disease up to four weeks after starting maribavir. Total participation duration depends on individual CMV clearance time.
CONDITIONS
Brief 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.
- Ability to understand and voluntarily sign informed consent.
- Willingness and ability to follow study visit schedule and protocol.
- Documented diagnosis of multiple myeloma, follicular lymphoma, or large B-cell lymphoma.
- Currently receiving bispecific antibodies such as Teclistamab, Elranatamab, Talquetamab, Cevostamab, ABBV383, Mosunetuzumab, Glofitamab, Epcoritamab, or Odronextamab.
- Documented clinically significant CMV infection, defined as CMV end-organ disease or CMV viremia ≥500 IU/mL in two consecutive assessments.
- ECOG performance status of 0, 1, or 2.
- For individuals of childbearing potential: negative pregnancy tests before treatment and agreement to ongoing testing.
- Use of effective contraception or true abstinence during treatment and for 90 days after last dose (for both males and females).
You will not qualify if you...
- Need for ganciclovir, valganciclovir, foscarnet, or cidofovir for non-CMV reasons or with maribavir co-administration.
- Known hypersensitivity to maribavir.
- CMV disease involving the central nervous system (except retinitis alone).
- Allogeneic stem cell transplant within 1 year or autologous transplant within 12 weeks prior to treatment.
- Active graft-versus-host disease in allogeneic transplant recipients.
- Significant medical condition, infection, lab abnormality, or psychiatric illness posing unacceptable risk.
- Conditions that may affect data interpretation.
- Creatinine clearance less than 10 mL/min or requiring dialysis.
- Liver enzymes (AST or ALT) greater than 5 times the upper normal limit.
- Total bilirubin greater than 3 times the upper normal limit (except Gilbert's syndrome).
- Gastrointestinal disease or surgery affecting maribavir absorption.
- Severe vomiting, diarrhea, or GI illness within 24 hours before first dose.
- Use of immunosuppressive medication within 14 days before treatment, except certain corticosteroids.
- Requirement for mechanical ventilation or vasopressors at enrollment.
- Positive for HIV, active or chronic hepatitis B 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From Week 1 until CMV clearance
Participants receive maribavir 400 mg twice daily starting from Week 1 and continuing until clearance of CMV, defined by specific laboratory criteria indicating reduced viral levels.
Weekly visits during treatment
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
Research Team
J
Ja Min Byun, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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