Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

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

NCT05645107 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Xembify

Study Locations (20)

Other

  • GC2202 Study Site 702 — Banja Luka
  • GC2202 Study Site 703 — Mostar
  • GC2202 Study Site 701 — Sarajevo
  • GC2202 Study Site 202 — Burgas
  • GC2202 Study Site 203 — Plovdiv
  • GC2202 Study Site 210 — Plovdiv
  • GC2202 Study Site 205 — Rousse
  • GC2202 Study Site 209 — Sofia
  • GC2202 Study Site 201 — Sofia
  • GC2202 Study Site 206 — Sofia
  • GC2202 Study Site 207 — Sofia
  • GC2202 Study Site 211 — Sofia
  • GC2202 Study Site 212 — Sofia
  • GC2202 Study Site 213 — Sofia

North Carolina

  • GC2202 Study Site 109 — Greenville
  • GC2202 Decentralized Study Site 114 — Morrisville

Florida

  • GC2202 Study Site 103 — St. Petersburg

Maryland

  • GC2202 Study Site 111 — Bethesda

Ohio

  • GC2202 Study Site 105 — Canton

South Carolina

  • GC2202 Study Site 110 — Rockville

Trial Details

FieldValue
Enrollment Target 386 participants
Start Date 2022-12-26
Est. Completion 2026-06
Phase Phase 3

Sponsor

Grifols Therapeutics

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05645107

The ClinicalTrials.gov registry entry for NCT05645107 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 386 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grifols Therapeutics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05645107 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Other, North Carolina, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05645107 about?

NCT05645107 is a clinical study titled "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". 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 ...

What is the current status of trial NCT05645107?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 386 participants. The study started on 2022-12-26. Estimated completion is 2026-06.

What conditions does trial NCT05645107 study?

This clinical trial studies the following conditions: Non-Hodgkin Lymphoma, Bacterial Infections, B-cell Chronic Lymphocytic Leukemia, Hypogammaglobulinemia, Multiple Myleoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05645107?

The interventions under investigation include: Placebo (DRUG), Xembify (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05645107?

This trial is sponsored by Grifols Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05645107 being conducted?

This trial has 20 study locations across Florida, Maryland, North Carolina, Ohio, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial