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NCT05645107 · ClinicalTrials.gov registry record · 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
A Phase 3 study of Non-Hodgkin Lymphoma and Bacterial Infections, sponsored by Grifols Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 386
- Enrollment target
- 20
- Study locations
NCT05645107: Recruiting Phase 3 study of Non-Hodgkin Lymphoma and Bacterial Infections, sponsored by Grifols Therapeutics.
NCT05645107 is a Phase 3 study of Non-Hodgkin Lymphoma and Bacterial Infections that is actively recruiting participants, run by Grifols Therapeutics. The registered enrollment target is 386 participants, above the 164-participant average among 106 other Non-Hodgkin Lymphoma trials with a reported enrollment target (135% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05645107, a Phase 3 study of Non-Hodgkin Lymphoma and Bacterial Infections, is actively recruiting participants, sponsored by Grifols Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 386 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 386 participants |
| Start Date | 2022-12-26 |
| Est. Completion | 2026-06 |
| Phase | Phase 3 |
What NCT05645107 shows while recruiting
NCT05645107 is an interventional study that assigns participants to a tested intervention. The registered 386 participants enrollment target is mid-sized for trials with a published cap, above the 164-participant average among 106 other Non-Hodgkin Lymphoma trials with a reported enrollment target (135% higher).
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.
NCT05645107 names 20 study sites across 6 states, led by Other, North Carolina, Florida.
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.
What interventions are being tested in trial NCT05645107?
The interventions under investigation include: Placebo (DRUG), Xembify (DRUG).
Who is sponsoring clinical trial NCT05645107?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05645107's enrollment target sits among peer trials
386 11th of 106 higher than 96 of 106 other Non-Hodgkin Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Hodgkin Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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