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NCT04965493 · ClinicalTrials.gov registry record · Phase 3
A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
A Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Loxo Oncology.
- Active
- Registry status
- Phase 3
- Development phase
- 600
- Enrollment target
- 20
- Study locations
NCT04965493 is a Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma that is active but no longer recruiting, run by Loxo Oncology. The registered enrollment target is 600 participants, above the 179-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (235% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT04965493, a Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, is active but no longer recruiting, sponsored by Loxo Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 600 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Rituximab
- DRUG Pirtobrutinib
Study Locations (20)
California
- University of California Irvine Medical Center - Orange
- Scripps Mercy Hospital - San Diego
- Providence Medical Foundation - Santa Rosa
Florida
- Florida Cancer Specialists - Fort Myers
- Cancer Specialists of North Florida -St Augustine - Saint Augustine
- Florida Cancer Specialists East - West Palm Beach
Arizona
- Ironwood Physicians, Ironwood Cancer and Research Centers - Chandler
- Mayo Clinic Hospital - Phoenix
Michigan
- St. Joseph Mercy Hospital - Ann Arbor
- University of Michigan - Ann Arbor
New York
- The Mount Sinai Hospital - New York
- Columbia University Medical Center - New York
Connecticut
- Stamford Hospital - Stamford
Iowa
- Mission Cancer and Blood - Des Moines
Kentucky
- Pikeville Medical Center, Inc. - Pikeville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2021-09-20 |
| Est. Completion | 2027-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04965493
The ClinicalTrials.gov registry entry for NCT04965493 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 179-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (235% higher). The listed sponsor is Loxo Oncology, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT04965493 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT04965493 about?
NCT04965493 is a clinical study titled "A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)". The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.
What is the current status of trial NCT04965493?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2021-09-20. Estimated completion is 2027-10.
What conditions does trial NCT04965493 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma.
What interventions are being tested in trial NCT04965493?
The interventions under investigation include: Venetoclax (DRUG), Rituximab (DRUG), Pirtobrutinib (DRUG).
Who is sponsoring clinical trial NCT04965493?
This trial is sponsored by Loxo Oncology, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04965493 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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