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NCT05471843 · ClinicalTrials.gov registry record · Phase 1
Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma
A Phase 1 study of Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma (MCL), sponsored by BeiGene.
- Active
- Registry status
- Phase 1
- Development phase
- 125
- Enrollment target
- 20
- Study locations
NCT05471843 is a Phase 1 study of Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma (MCL) that is active but no longer recruiting, run by BeiGene. The registered enrollment target is 125 participants, above the 103-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (21% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT05471843, a Phase 1 study of Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma (MCL), is active but no longer recruiting, sponsored by BeiGene.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 125 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417 (sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of BGB-11417 monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.
Conditions Studied
Interventions
- DRUG BGB-11417
Study Locations (20)
Other
- Hospital Aleman - Buenos Aires
- Az Sint Jan Brugge - Bruges
- Universitair Ziekenhuis Gent - Ghent
- University Hospitals Leuven - Leuven
- AZ DELTA - Roeselare
- Hospital Erasto Gaertner - Curitiba
- Hospital Mae de Deus - Porto Alegre
Maryland
- Luminis Health Anne Arundel Medical Center - Annapolis
- Maryland Oncology Hematology, Pa - Columbia
Alabama
- University of Alabama At Birmingham Hospital - Birmingham
District of Columbia
- Medstar Georgetown University Hospital - Washington D.C.
Indiana
- Fort Wayne Medical Oncology and Hematology - Fort Wayne
Iowa
- Des Moines Oncology Research Association - Des Moines
Louisiana
- Tulane Cancer Center - New Orleans
Missouri
- University of Missouri Hospital, Ellis Fischel Cancer Center - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2022-09-05 |
| Est. Completion | 2027-01-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05471843
The ClinicalTrials.gov registry entry for NCT05471843 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 103-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (21% higher). The listed sponsor is BeiGene, which has 65 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which BGB-11417 is the first listed.
NCT05471843 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, Maryland, Alabama.
Frequently Asked Questions
What is clinical trial NCT05471843 about?
NCT05471843 is a clinical study titled "Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma". The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417 (sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of BGB-11417 monothe...
What is the current status of trial NCT05471843?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 125 participants. The study started on 2022-09-05. Estimated completion is 2027-01-31.
What conditions does trial NCT05471843 study?
This clinical trial studies the following conditions: Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma (MCL), Relapsed Mantle Cell Lymphoma.
What interventions are being tested in trial NCT05471843?
The interventions under investigation include: BGB-11417 (DRUG).
Who is sponsoring clinical trial NCT05471843?
This trial is sponsored by BeiGene, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05471843 being conducted?
This trial has 20 study locations across Alabama, District of Columbia, Indiana, Iowa, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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