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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
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years 2 months later May 2026 → Aug 2029
See other at-risk trials from Grifols Therapeutics LLC

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 25 words
    • Study sites revised (62)
  2. Primary completion pushed from May 2026 to Aug 2029
    • Study completion pushed from Jun 2026 to Aug 2029
    v11
  3. Study sites: 61 to 62
    • Eligibility criteria expanded, about 39 words
    v10
  4. Study sites: 57 to 61v9
  5. Eligibility criteria shortened, about 38 wordsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 39 to 57v7
  2. Study sites: 28 to 39
    • Eligibility criteria expanded, about 49 words
    • Secondary endpoints: details revised at 13 of 13 entries
    • Study title expanded, about 1 word
    v6
  3. Study sites: 26 to 28v5
  4. Study sites: 3 to 26v4
  5. Study sites: 2 to 3v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 17, 2022 to Dec 26, 2022
    • Site details revised at 2 of 2 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05645107
Lead Sponsor Grifols Therapeutics LLC
Conditions
(from sponsor)		 Hypogammaglobulinemia, Bacterial Infections, B-cell Chronic Lymphocytic Leukemia, Multiple Myleoma, Non-Hodgkin Lymphoma
Related terms Agammaglobulinemia, Bacterial Infections, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin
Enrollment 386 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov