Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Loxo Oncology.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assessed by blinded independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018
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 |
What the registry record for NCT04965493 still lists
NCT04965493 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 179-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (235% higher).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04965493's enrollment target sits among peer trials
600 14th of 187 higher than 174 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Long-term Extension Study of PCI-32765 (Ibrutinib)
RECRUITING · Phase 3
-
A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
RECRUITING · Phase 3
-
A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)
RECRUITING · Phase 3
-
A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors
RECRUITING · Phase 3
-
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
RECRUITING · Phase 3
-
A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00004317 · 600 participants · Phase 4
Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis
- NCT00209235 · 600 participants · NA
Albright Hereditary Osteodystrophy: Natural History, Growth, and Cognitive/Behavioral Assessments
- NCT01473784 · 600 participants · NA
Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck
- NCT01866371 · 600 participants
High Resolution Retinal Imaging
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI