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Bruton's Tyrosine Kinase (BTK) Inhibitor

JNJ-67856633 + Ibrutinib for Lymphoma and Leukemia

Q: What are the overarching aims of this clinical inquiry?

<p>According to the trial sponsor, Janssen Research &#x26; Development LLC, Percentage of Participants with Dose-Limiting Toxicity (DLT) will be assessed as primary outcome over a span of two years and nine months. As secondary outcomes, this medical study seeks to measure Time to First Response (TTR), Plasma Concentration of JNJ-67856633 and <a href="https://www.withpower.com/clinical-trials/ibrutinib">Ibrutinib</a>, and Major Response Rate (MaRR).</p>

Phase 1

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cardiac parameters within the specified range

Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years and 9 months

Awards & highlights

Study Summary

This trial is testing a combination of two drugs to treat B cell NHL and CLL. They are testing to see what is the maximum safe dose and if the combination is effective.

Who is the study for?

This trial is for adults with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukemia. Participants must have available tumor tissue, good organ function, and be in fair health (ECOG grade 0-1). Women who can bear children must use effective contraception and not plan pregnancy or breastfeeding. People are excluded if they've had bad reactions to MALT1 inhibitors before or have active brain involvement by cancer.Check my eligibility

What is being tested?

The study is testing the combination of a new drug called JNJ-67856633 with an existing drug named Ibrutinib to find a safe dosage level and see how well it works against certain blood cancers like NHL and CLL. The goal is to establish the recommended dose for further studies.See study design

What are the potential side effects?

Potential side effects may include typical reactions seen with cancer treatments such as nausea, fatigue, diarrhea, risk of infection due to low blood cell counts, liver problems indicated by abnormal tests, and possibly heart issues which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart function is within the normal range.

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I am fully active or can carry out light work.

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I have available tumor tissue for testing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years and 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years and 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants with Adverse Events (AEs) by Severity

Percentage of Participants with Dose-Limiting Toxicity (DLT)

Secondary outcome measures

Plasma Concentration of JNJ-67856633 and Ibrutinib

Trial Design

1Treatment groups

Experimental Treatment

Group I: JNJ-67856633 and IbrutinibExperimental Treatment2 Interventions

Participants will receive JNJ-67856633 together with Ibrutinib orally on a 21-day cycle. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by Study Evaluation Team (SET).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibrutinib

2014

Completed Phase 3

~1880

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,263 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,860 Total Patients Enrolled

Media Library

Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04876092 — Phase 1

Non-Hodgkin's Lymphoma Clinical Trial 2023: Ibrutinib Highlights & Side Effects. Trial Name: NCT04876092 — Phase 1

Non-Hodgkin's Lymphoma Research Study Groups: JNJ-67856633 and Ibrutinib

Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04876092 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given its seal of approval for JNJ-67856633?

"JNJ-67856633 is still in its first phase of clinical trials, so limited data exists to support safety and efficacy. Consequently, this drug was given a rating of 1 on our internal hazard scale at Power."

Answered by AI

What is the current population size of participants in this experiment?

"Currently, this trial is not taking on new applicants. The initial posting for the study was made on July 28th 2021 and has recently been revised as of November 3rd 2022. If you are seeking alternative trials, there are currently over two-thousand studies recruiting participants with lymphoma, diffuse and one hundred fifty-five trials looking to enrol patients into JNJ-67856633 research."

Answered by AI

What are the overarching aims of this clinical inquiry?

"According to the trial sponsor, Janssen Research & Development LLC, Percentage of Participants with Dose-Limiting Toxicity (DLT) will be assessed as primary outcome over a span of two years and nine months. As secondary outcomes, this medical study seeks to measure Time to First Response (TTR), Plasma Concentration of JNJ-67856633 and Ibrutinib, and Major Response Rate (MaRR)."

Answered by AI

Are there any openings available for individuals to join this research project?

"This medical trial is no longer recruiting. It was initially posted on July 28th, 2021 and the details were last updated November 3rd 2022. If you are looking for new studies relating to lymphoma or JNJ-67856633 related treatments, there currently exist 2877 trials with open registration and 155 studies actively enrolling participants respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in B-cell NHL and CLL

2021. "A Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in B-cell NHL and CLL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04876092.

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