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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: Recruiting Phase 2 study of Small Lymphocytic Lymphoma and Leukemia, Lymphocytic, Chronic, B-Cell, sponsored by Janssen Research & Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Best ORR is defined as the percentage of participants who achieve complete remission (CR), complete remission with an incomplete marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria as assessed by investigator.
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 |
What NCT05963074 shows while recruiting
NCT05963074 is an interventional study that assigns participants to a tested intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, above the 189-participant average among 81 other Small Lymphocytic Lymphoma trials with a reported enrollment target (69% higher).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
Similar trials for Small Lymphocytic Lymphoma
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 NCT05963074's enrollment target sits among peer trials
320 15th of 81 higher than 67 of 81 other Small Lymphocytic Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Small Lymphocytic Lymphoma 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
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