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Bruton's Tyrosine Kinase (BTK) Inhibitor

JNJ-67856633 + Ibrutinib for Lymphoma and Leukemia

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
Must not have
Prior treatment with JNJ-67856633 or another MALT1 inhibitor that is associated with disease progression or intolerable toxicities
Known (active) Central Nervous System (CNS) involvement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years and 9 months
Awards & highlights

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had side effects or my disease worsened after treatment with a MALT1 inhibitor.
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My cancer has spread to my brain or spinal cord.

Timeline

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 4
~1890

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Hodgkin's Lymphoma (NHL) often involve targeting B cell pathways, such as with Bruton tyrosine kinase (BTK) inhibitors like ibrutinib. BTK inhibitors block the BTK enzyme, essential for B cell receptor signaling, thereby disrupting the survival and proliferation of malignant B cells. Additionally, agents like JNJ-67856633 likely target other components of the B cell signaling pathways, further impairing the growth and survival of lymphoma cells. This targeted approach is crucial for NHL patients as it offers the potential for more effective and less toxic treatments compared to traditional chemotherapy.
Response to second-line therapy defines the potential for cure in patients with recurrent diffuse large B-cell lymphoma: implications for the development of novel therapeutic strategies.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
980 Previous Clinical Trials
6,384,248 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
749 Previous Clinical Trials
3,960,902 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
~5 spots leftby Nov 2024