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RECRUITING Phase 2

A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia

NCT05963074 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 320 participants
Start Date 2024-05-30
Est. Completion 2029-03-19
Phase Phase 2

Sponsor

Janssen Research & Development

442 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05963074 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05963074?

The interventions under investigation include: Venetoclax (DRUG), Ibrutinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05963074?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial