None listed
Conditions
Interventions
Drug : Maribavir should be administered orally at 400 mg twice daily until the plasma CMV DNA titer is below the limit of quantification (i.e., below the lower limit of quantitation [LLOQ]) or until i
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Subjects must be at least 19 years of age at the time of signing the informed consent form (ICF). ? Subjects must understand the purpose of the study and voluntarily sign the informed consent form (ICF) before initiating any study-related evaluations or treatments. ? Subjects must have the willingness and ability to comply with the study visit schedule and other requirements specified in the clinical trial protocol. ? The subject must be a patient diagnosed with one of the following conditions and receiving treatment with one of the bispecific antibodies specified below: 1)Multiple Myeloma:Teclistamab.Elanatumab,Talquetamab,Cevostamab,ABBV383 2)Follicular Lymphoma / Large B-Cell Lymphoma: Mousnetuzumab,Glofitamab,Epocritamab,Odronectamab ? Subjects with clinically significant CMV infection. This is defined as meeting one or more of the following conditions: A. Development of CMV organ involvement disease B. Prophylactic anti-CMV therapy initiated based on the subject's clinical status when CMV viremia is confirmed. The viral load threshold for initiating prophylactic treatment is plasma CMV DNA =500 IU/mL measured consecutively on two separate days at least 24 hours apart. ? Note: Patients who previously received treatment with ganciclovir, valganciclovir, cidofovir, or foscarnet are also eligible for this study. ? Subjects must have an ECOG performance status of 0, 1, or 2. ? Individuals of childbearing potential (IOCBP) must meet the following conditions: A. Prior to initiation of study treatment, two negative pregnancy test results confirmed by the investigator must be obtained, and the subject must agree to ongoing pregnancy testing during the study period and after treatment completion. This applies even in cases of *complete sexual abstinence (no heterosexual intercourse whatsoever). B. *Must agree to either completely avoid heterosexual intercourse or consistently use two methods of contraception for pregnancy prevention and be able to comply. If abstinence is chosen, this status must be reconfirmed monthly by the study team, and supporting documentation must be provided. If choosing contraception, a highly effective contraceptive method must be used in combination with an additional effective barrier method. These two contraceptive methods must be maintained without interruption starting 28 days before the initiation of study drug administration, throughout the entire study drug administration period (including the dose discontinuation period), and for at least 90 days after the final dose of maribavir. ? Note: An individual of childbearing potential (IOCBP) refers to a person who meets all of the following conditions: 1) Has experienced menarche (first menstrual period) at least once, 2) Has no history of hysterectomy (surgical removal of the uterus), bilateral salpingectomy (surgical removal of both fallopian tubes), or bilateral oophorectomy (surgical removal of both ovaries), and 3) has not reached natural menopause (defined as the absence of menstruation for at least 12 consecutive months without other medical causes, e.g., amenorrhea following cancer treatment; amenorrhea due to specific medical causes does not exclude fertility potential) within the past 12 months (i.e., having menstruated even once within the last 12 months excludes natural menopause). ? Male subjects must meet the following conditions: A. *Agree to completely avoid heterosexual sexual contact, or agree to use condoms during sexual intercourse with
Exclusion criteria
Exclusion criteria: ? Subjects requiring treatment with ganciclovir, valganciclovir, foscarnet, or cidofovir for conditions other than CMV at the start of study drug administration, or subjects requiring concomitant administration of maribavir for CMV infection ? Subjects with a history of hypersensitivity to maribavir ? Tissue-invasive CMV disease with central nervous system involvement (however, retinitis without central nervous system disease is permitted) ? Subjects who received an allogeneic hematopoietic stem cell transplant within one year of prior treatment or an autologous hematopoietic stem cell transplant within 12 weeks prior to the start of study drug administration. For subjects who received an allogeneic hematopoietic stem cell transplant, there must be no evidence of active graft-versus-host disease (GVHD). ? Subjects with active or uncontrolled infections, abnormal test results, psychiatric disorders, or other serious medical conditions posing a high risk of treatment-related complications during study participation ? Subjects whose inclusion could potentially confound the interpretation of study data ? Subjects with the following abnormal test results: A. Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI equation <30 mL/min/1.73m² or requiring dialysis. B. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels exceeding 5 times the upper limit of normal (ULN). Serum total bilirubin exceeding 3 times ULN (except in documented cases of Gilbert's syndrome). C. Serum total bilirubin levels exceeding 3 times the upper limit of normal (ULN) (except in cases of clearly diagnosed Gilbert's syndrome). ? Subjects with gastrointestinal disease or who have undergone gastrointestinal surgery (e.g., gastric bypass surgery) that could significantly alter the absorption of maribavir and/or other oral study drugs ? Subjects experiencing severe vomiting, diarrhea, or other serious gastrointestinal disease within 24 hours of the first study drug dose, making oral administration difficult ? Subjects who took immunosuppressants within 14 days prior to study drug initiation. However, the following are exceptions: a. Corticosteroids administered via nasal, inhaled, topical, or local injection (e.g., intra-articular injection) b. Prednisone 10 mg/day or less, or equivalent systemic steroid dose c. Pre-treatment steroids for hypersensitivity prevention (e.g., steroids prior to CT scan) ? Subjects requiring mechanical ventilation or vasopressors for hemodynamic support at the time of registration ? Subjects testing positive for one or more of the following infectious diseases: A. Known human immunodeficiency virus (HIV) positive status B. Positive serological test for hepatitis B. (Acute or chronic hepatitis with positive hepatitis B surface antigen [HBsAg]) For those recovered from past infection (HBsAg negative but anti-HBcAb positive and/or anti-HBsAb positive), HBV DNA must be measured via real-time polymerase chain reaction (PCR). Patients with a positive PCR result are excluded from the study. i. Exception: PCR testing is waived if serological results are determined to be due to HBV vaccination (only anti-HBsAb positive with clear history of prior vaccination). ii. Exception: If anti-HBcAb positive, HBsAg negative, and anti-HBsAb negative, inclusion is possible if PCR is negative. C. If anti-HCV antibody is positive and HCV RNA quantitative test is simultaneously positive ? Women who are pregnant or breastfeedi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CMV DNA Clearance Rate Following Maribavir Treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to CMV DNA Clearance | — |
Countries
Korea, Republic of
Contacts
Public ContactJamin Byun
Seoul National University Hospital
Outcome results
None listed