[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594044":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":40,"collaborators":20,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":20,"enrollmentInfo":54,"targetDuration":20,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":29,"whyStopped":20,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Maribavir arm","EXPERIMENTAL","The Maribavir arm includes patients with a confirmed diagnosis of multiple myeloma, follicular lymphoma, or large B-cell lymphomas (including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, transformed follicular lymphoma, or transformed marginal zone lymphoma) who are receiving bispecific antibody therapy. Patients must have documented clinically significant CMV infection, defined by either CMV end-organ disease or initiation of pre-emptive therapy based on plasma CMV viremia ≥ 500 IU\u002FmL in two consecutive assessments and relevant clinical findings.",[13],"Drug: Maribavir",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Maribavir","Participants will receive maribavir 400 mg twice daily starting from Week 1 and continuing until clearance of CMV. CMV clearance is defined as either an unquantifiable plasma CMV DNA titer (i.e., below the lower limit of quantification \\[LLOQ\\]) as assessed by the local laboratory, or a CMV DNA level below 500 IU\u002FmL in plasma without evidence of CMV disease.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Ja Min Byun, MD, PhD","CONTACT","82-2-2072-7215","jaminbyun@snu.ac.kr",[28],{"facility":5,"status":29,"city":30,"state":20,"zip":20,"country":31,"countryCode":20,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"RECRUITING","Seoul","South Korea",{"type":33,"coordinates":34},"Point",[35,36],126.9784,37.566,{"lat":36,"lon":35},[39],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","JaMin Byun","Professor, MD, PhD","100594044","phase-2-phase-ii-trial-of-maribavir-for-cmv-in-patients-with-lymphoid-malignancy-on-bispecific-antibodies-100594044",false,"NCT07014319","Phase II Trial of Maribavir for CMV in Patients With Lymphoid Malignancy on Bispecific Antibodies","Maribavir Treatment of Cytomegalovirus for Lymphoid Malignancy Patients Undergoing Bispecific Antibodies","MALMBA","Inclusion Criteria:\n\n* Subject is ≥19 years of age at the time of signing the informed consent form (ICF).\n\n  * Subject must understand and voluntarily sign an ICF prior to any study-related assessments\u002Fprocedures.\n\n    ③ Subject is willing and able to adhere to the study visit schedule and protocol requirements.\n\n    ④ Subject has documented diagnosis of 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), and is receiving one of the following bispecific antibodies: Multiple Myeloma: Teclistamab, Elranatamab, Talquetamab, Cevostamab, ABBV383 Lymphomas: Mosunetuzumab, Glofitamab, Epcoritamab, Odronextamab\n\n    ⑤ Subject has documented clinically significant CMV infection, defined as: A. Onset of CMV end-organ disease (Appendix 1), or B. Initiation of anti-CMV pre-emptive therapy based on documented CMV viremia ≥500 IU\u002FmL in two consecutive assessments (≥1 day apart) and the clinical condition of the subject Note: Prior therapy with ganciclovir, valganciclovir, foscarnet, or cidofovir is allowed.\n    * 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.\n\nB. Commit to true abstinence or use two forms of contraception (one highly effective + one barrier method) starting 28 days prior to treatment, during treatment, and for 90 days after the last dose.\n\nNote: Definition of IOCBP includes menstruating individuals who are not postmenopausal for 12+ months or have not undergone permanent sterilization.\n\n⑧ Male subjects must: A. Practice true abstinence (monthly verified) or use a condom with partners who are pregnant or of childbearing potential during treatment, dose interruptions, and for 90 days after last dose, regardless of vasectomy status.\n\n⑨ Male subjects must not donate sperm during treatment and for 90 days after the last dose.\n\n⑩ Female subjects must not donate eggs during treatment and for 90 days after the last dose.\n\nExclusion Criteria:\n\n* Requires ganciclovir, valganciclovir, foscarnet, or cidofovir for non-CMV indications or requires co-administration with maribavir.\n\n  * 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.\n\nAllogeneic SCT recipients must not have active GVHD. ⑤ Any significant medical condition, infection, lab abnormality, or psychiatric illness posing unacceptable risk.\n\n* Any condition that may confound data interpretation. ⑦ Any of the following laboratory abnormalities:\n\nA. Creatinine clearance \\\u003C10 mL\u002Fmin or requiring dialysis (Cockcroft-Gault formula used):\n\n* Males: CrCl = (140 - age) × weight (kg) \u002F (72 × creatinine \\[mg\u002FdL\\])\n* Females: Multiply above result by 0.85 B. AST or ALT \\>5 × ULN C. Total bilirubin \\>3 × ULN (except Gilbert's syndrome)\n\n  * Gastrointestinal disease or surgery (e.g., gastric bypass) that affects maribavir absorption.\n\n    * Severe vomiting, diarrhea, or GI illness within 24 hours before first dose. ⑩ Use of immunosuppressive medication within 14 days before study treatment, except: A. Intranasal, inhaled, topical, or local corticosteroid injections B. Systemic corticosteroids ≤10 mg\u002Fday of prednisone or equivalent C. Premedication for hypersensitivity (e.g., CT scan premed) ⑪ Requires mechanical ventilation or vasopressors at enrollment. ⑫ Positive for HIV, active or chronic HBV, active HAV or HCV: A. Known HIV infection B. Positive HBsAg (acute or chronic); HBV DNA PCR required for anti-HBcAb(+) patients.\n* EXCEPTION: Isolated anti-HBs with known HBV vaccination\n* EXCEPTION: anti-HBc(+), HBsAg(-), anti-HBsAb(-) with negative HBV DNA C. HCV antibody and RNA positive ⑬ Pregnant, breastfeeding, or planning pregnancy during study participation.","ALL","19 Years",{"count":55,"type":56},20,"ESTIMATED","INTERVENTIONAL",[59],"PHASE2","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",[62],"Cytomegalovirus (CMV)",[64,65,66],"CMV","MM","Lymphoma","2025-11-26",{"date":69,"type":70},"2025-12-04","ACTUAL",{"date":72,"type":70},"2025-11-03",{"date":74,"type":56},"2028-01-31",{"name":5,"class":6},1]