{"entity":{"id":"nct05645107","kind":"trial","name":"A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma","aka":["EXCELL"],"tldr":"A phase 3 trial of Xembify in chronic lymphocytic leukaemia and non-Hodgkin lymphoma, run by Grifols Therapeutics LLC, now recruiting.","summary":"A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma is a phase 3 interventional study registered as NCT05645107 by Grifols Therapeutics LLC, with 386 participants planned, started 2022-12-26 and due to reach its primary completion in 2029-08. Interventions recorded: Xembify and Placebo.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05645107","url":"https://clinicaltrials.gov/study/NCT05645107"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cll","non-hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["grifols"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05645107","phase":"3","setting":"A Randomized, Multi-Center, Parallel, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment Compared to Placebo Plus Standard Medical Treatment to Prevent Infections in Patients With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma","sponsor":"Grifols Therapeutics LLC","participation":[{"nct":"NCT05645107","source":"https://clinicaltrials.gov/study/NCT05645107","fetchedAt":"2026-10-07T16:53:48.601Z","studySha256":"f0f6bc065d8061bdc71c7dd21fb4eca4b7fbdb4d952b9c0b4a49f33bb3a6b8f7","overallStatus":"RECRUITING","lastUpdatePosted":"2026-09-30","leadSponsor":"Grifols Therapeutics LLC","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":386,"enrolmentType":"ESTIMATED","siteCount":62,"recruitingSiteCount":56,"countries":["Bosnia and Herzegovina","Bulgaria","Croatia","Hungary","Poland","Romania","Serbia","United States"]}],"started":"2022-12-26","startedType":"actual","enrolled":386,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05645107/","neighbours":{"cancer":[{"id":"cll","kind":"cancer","name":"Chronic lymphocytic leukaemia","route":"/cancers/cll/"},{"id":"non-hodgkin-lymphoma","kind":"cancer","name":"Non-Hodgkin lymphoma (all types)","route":"/cancers/non-hodgkin-lymphoma/"}],"company":[{"id":"grifols","kind":"company","name":"Grifols","route":"/companies/grifols/"}]}}