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NCT04662255 · ClinicalTrials.gov registry record · Phase 3
Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)
A Phase 3 study of Lymphoma, Mantle-Cell, sponsored by Loxo Oncology.
- Active
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT04662255: Active Phase 3 study of Lymphoma, Mantle-Cell, sponsored by Loxo Oncology.
NCT04662255 is a Phase 3 study of Lymphoma, Mantle-Cell that is active but no longer recruiting, run by Loxo Oncology. The registered enrollment target is 500 participants, above the 165-participant average among 7 other Lymphoma, Mantle-Cell trials with a reported enrollment target (203% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04662255, a Phase 3 study of Lymphoma, Mantle-Cell, is active but no longer recruiting, sponsored by Loxo Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.
Primary Outcome
Assessed per Lugano criteria
Conditions Studied
Interventions
- DRUG Zanubrutinib
- DRUG Pirtobrutinib
- DRUG Acalabrutinib
- DRUG Ibrutinib
Study Locations (20)
Florida
- Mayo Clinic in Florida - Jacksonville
- Oncology-Hematology Associates of West Broward - Tamarac
- Florida Cancer Specialists East - West Palm Beach
North Carolina
- Messino Cancer Center - Asheville
- Levine Cancer Institute - Charlotte
- Wake Forest University School of Medicine - Winston-Salem
Kentucky
- University of Kentucky Markey Cancer Center - Lexington
- Mercy Health-Paducah Medical Oncology and Hematology - Paducah
New York
- Columbia University Medical Center - New York
- Memorial Sloan Kettering Cancer Center - New York
Alaska
- Alaska Oncology and Hematology, LLC - Anchorage
Arizona
- Arizona Oncology Associates, P.C. - HOPE - Phoenix
California
- UCLA Medical Center - Los Angeles
Colorado
- USO-Rocky Mountain Cancer Center - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2021-04-08 |
| Est. Completion | 2028-04 |
| Phase | Phase 3 |
What the registry record for NCT04662255 still lists
NCT04662255 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 165-participant average among 7 other Lymphoma, Mantle-Cell trials with a reported enrollment target (203% higher).
The record links to 1 condition, with Lymphoma, Mantle-Cell appearing as the primary indexed condition, and to 4 interventions - of which Zanubrutinib is the first listed.
NCT04662255 names 20 study sites across 14 states, led by Florida, North Carolina, Kentucky.
Frequently Asked Questions
What is clinical trial NCT04662255 about?
NCT04662255 is a clinical study titled "Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)". This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation ...
What is the current status of trial NCT04662255?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2021-04-08. Estimated completion is 2028-04.
What conditions does trial NCT04662255 study?
This clinical trial studies the following conditions: Lymphoma, Mantle-Cell.
What interventions are being tested in trial NCT04662255?
The interventions under investigation include: Zanubrutinib (DRUG), Pirtobrutinib (DRUG), Acalabrutinib (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT04662255?
This trial is sponsored by Loxo Oncology, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04662255 being conducted?
This trial has 20 study locations across Alaska, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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