Clinical Trial

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

Study acronym: EXCELL
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The primary purpose of the study is to evaluate whether biweekly administered XEMBIFY® plus Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per participant per year in B-cell CLL, MM, and NHL participants with hypogammaglobulinemia (HGG) in comparison to the Placebo plus SMT group.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-05 -> 2029-08 2026-07-30
minor Completion pushed: 2026-06 -> 2029-08 2026-07-30
Trial Details
NCT Number NCT05645107
Lead Sponsor Grifols Therapeutics LLC
Conditions Hypogammaglobulinemia, Bacterial Infections, B-cell Chronic Lymphocytic Leukemia, Multiple Myleoma, Non-Hodgkin Lymphoma
Enrollment 386 participants
Start Date 2022-12-26
Primary Completion 2029-08 (estimated)
Study Completion 2029-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-29