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NCT05963074 · ClinicalTrials.gov registry record · Phase 2
A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia
A Phase 2 study of Small Lymphocytic Lymphoma and Leukemia, Lymphocytic, Chronic, B-Cell, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 320
- Enrollment target
- 20
- Study locations
NCT05963074 is a Phase 2 study of Small Lymphocytic Lymphoma and Leukemia, Lymphocytic, Chronic, B-Cell that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 320 participants, above the 189-participant average among 81 other Small Lymphocytic Lymphoma trials with a reported enrollment target (69% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT05963074, a Phase 2 study of Small Lymphocytic Lymphoma and Leukemia, Lymphocytic, Chronic, B-Cell, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 320 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of ibrutinib + venetoclax (I+V) and ibrutinib monotherapy regimens in which dosing of ibrutinib is either proactively reduced or reactively modified in response to adverse events (AEs).
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Ibrutinib
Study Locations (20)
California
- The Oncology Institute Clinical Research - Cerritos
- Cancer and Blood Specialty Clinic - Los Alamitos
- SLO Oncology and Hematology Health Center - San Luis Obispo
- Providence Medical Foundation - Santa Rosa
- PIH Health Hospital - Whittier
Florida
- Mount Sinai Medical Center Campus - Miami Beach
- The Oncology Institute - North Miami Beach
- Mid Florida Hematology Oncology - Orange
Illinois
- Hope and Healing Cancer Services - Hinsdale
- Springfield Clinic - Springfield
New Jersey
- Hunterdon Hematology Oncology - Flemington
- Summit Medical Group - Florham Park
Colorado
- Grand Valley Oncology - Grand Junction
Idaho
- Boise VA Medical Center - Boise
Iowa
- Iowa City VA Health Care System - Iowa City
Minnesota
- Minnesota Oncology Hematology P A - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2024-05-30 |
| Est. Completion | 2029-03-19 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05963074
The ClinicalTrials.gov registry entry for NCT05963074 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 189-participant average among 81 other Small Lymphocytic Lymphoma trials with a reported enrollment target (69% higher). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Small Lymphocytic Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Venetoclax is the first listed.
NCT05963074 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT05963074 about?
NCT05963074 is a clinical study titled "A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia". The purpose of this study is to evaluate the efficacy and safety of ibrutinib + venetoclax (I+V) and ibrutinib monotherapy regimens in which dosing of ibrutinib is either proactively reduced or reactively modified in response to adverse events (AEs).
What is the current status of trial NCT05963074?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 320 participants. The study started on 2024-05-30. Estimated completion is 2029-03-19.
What conditions does trial NCT05963074 study?
This clinical trial studies the following conditions: Small Lymphocytic Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell.
What interventions are being tested in trial NCT05963074?
The interventions under investigation include: Venetoclax (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT05963074?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05963074 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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