JNJ-67856633 + Ibrutinib for Lymphoma and Leukemia

Recruiting in Palo Alto (17 mi)

+31 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing two drugs, JNJ-67856633 and ibrutinib, to find the safest and most effective dose for treating certain blood cancers. It targets patients with B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL), who may not respond well to standard treatments. These drugs work by blocking proteins that help cancer cells grow.

Eligibility Criteria

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.

Inclusion Criteria

Willing and able to adhere to the lifestyle restrictions specified in this protocol

My heart function is within the normal range.

I am fully active or can carry out light work.

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Exclusion Criteria

I had side effects or my disease worsened after treatment with a MALT1 inhibitor.

My cancer has spread to my brain or spinal cord.

Treatment Details

Interventions

Ibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)
JNJ-67856633 (MALT1 Inhibitor)

Trial OverviewThe 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.

Participant Groups

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).

Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Imbruvica for: