[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565259":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":59,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":25,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":25,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Interrupted letermovir prophylaxis","EXPERIMENTAL","Participants assigned to the investigational group, you will also receive letermovir at first, but depending on the result of the study blood tests, your dose may be paused as long as your immune system shows an immune response against CMV.",[13,14],"Procedure: Hematopoietic Cell Transplant","Drug: Letermovir",{"label":16,"type":10,"description":17,"interventionNames":18},"Standard letermovir prophylaxis","Participants assigned to the standard care group, you will receive treatment with letermovir every day to prevent CMV infection.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Hematopoietic Cell Transplant","Participants choices may include to receive standard post-transplant virus prevention with letermovir or other standard drugs without being part of this study. Participants may choose to receive other investigational therapy, if available.\n\nThese alternative treatments have risks and benefits that may be the same or different than those in this research study.",[9,16],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DRUG","Letermovir","Given by PO",[9,16],[32],{"name":33,"affiliation":5,"role":34},"Fareed Khawaja, MBBS","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","(281) 610-0253","fkhawaja@mdanderson.org",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"The University of Texas MD Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-95.36327,29.76328,{"lat":53,"lon":52},[56,58],{"name":33,"role":37,"phone":57,"phoneExt":25,"email":39},"281-610-0253",{"name":33,"role":34,"phone":25,"phoneExt":25,"email":25},{"type":60,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100565259","the-use-of-cytomegalovirus-cell-mediated-immunity-to-optimize-the-duration-of-letermovir-prophylaxis-in-hematopoietic-cell-transplant-recipients-100565259",false,"NCT06639854","The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophylaxis in Hematopoietic Cell Transplant Recipients","Inclusion criteria\n\n1. Allogeneic HCT recipients with positive CMV serostatus\n2. On letermovir prophylaxis at day 90 post transplant (+\u002F- 7 days)\n3. At high risk for CMV reactivation after day +100:\n\n   1. Prior or active graft versus host disease requiring systemic steroids\n   2. Mismatch stem cell donor (includes haploidentical, mismatch unrelated donor (MMUD), match related donor with at least one mismatch at one of the three specified HLA gene loci (HLA-A, HLA-B, or HLA-DR) and cord donor recipients)\n   3. Received T cell depletion or anti thymoglobulin during conditioning\n   4. CMV reactivation prior to day 100 post transplant\n   5. On steroids at any dose within 2 weeks of enrollment\n\nExclusion criteria\n\n1. Patients under the age of 18\n2. Patients are discharged from our institution and unwilling to come back for follow up\n3. Patients are actively undergoing treatment for CS-CMVi at time of screening. Prior CS-CMVi is not an exclusion from study.\n4. Patients are allergic or intolerant to letermovir or have history of letermovir resistant CMV infection.\n5. Not able to procure letermovir for extended prophylaxis beyond day +100.","ALL","18 Years",{"count":70,"type":71},105,"ESTIMATED","INTERVENTIONAL",[74],"NA","The goal of this laboratory research study is to learn if interrupting a patient's letermovir dosing based on their immune system response can help HSC transplant patients avoid post-treatment CMV infections better than taking letermovir every day without interruption.",[77,22],"Cytomegalovirus Cell Mediated Immunity","2026-06-12",{"date":80,"type":81},"2026-06-15","ACTUAL",{"date":83,"type":81},"2024-11-20",{"date":85,"type":71},"2027-12-31",{"name":5,"class":6},1]