NCT04876092

Brief Summary

The purpose of this study is to determine the safety and recommended Phase 2 dose (RP2D) of JNJ-67856633 and ibrutinib in combination in participants with B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2021

Typical duration for phase_1

Geographic Reach
4 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 28, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2025

Completed
Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

3.6 years

First QC Date

May 4, 2021

Last Update Submit

August 20, 2025

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants with Dose-Limiting Toxicity (DLT)

    Percentage of Participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematological toxicity or hematological toxicity.

    Up to 21 days

  • Percentage of Participants with Adverse Events (AEs) by Severity

    Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.

    Up to 2 years and 9 months

Secondary Outcomes (1)

  • Plasma Concentration of JNJ-67856633 and Ibrutinib

    Up to 2 years and 9 months

Study Arms (1)

JNJ-67856633 and Ibrutinib

EXPERIMENTAL

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).

Drug: JNJ-67856633Drug: Ibrutinib

Interventions

JNJ-67856633DRUG

Participants will receive JNJ-67856633 orally.

JNJ-67856633 and Ibrutinib
IbrutinibDRUG

Participants will receive Ibrutinib orally.

Also known as: JNJ-54179060
JNJ-67856633 and Ibrutinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
  • Cardiac parameters within the specified range
  • Women of childbearing potential must agree to all of the following during the study and for 3 months after the last dose of study drug: a) use a barrier method of contraception; b) use a highly effective contraceptive methods; c) not to donate eggs (ova, oocytes) or freeze them for future use for the purposes of assisted reproduction during the study; d) not to plan to become pregnant; e) not to breast-feed
  • Willing and able to adhere to the lifestyle restrictions specified in this protocol
  • Participants must have tumor tissue availability
  • Adequate organ functions

You may not qualify if:

  • Known (active) Central Nervous System (CNS) involvement
  • Prior treatment with JNJ-67856633 or another MALT1 inhibitor that is associated with disease progression or intolerable toxicities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

CHRU de Lille Hopital Claude Huriez

Lille, 59037, France

Location

Institut Paoli Calmettes

Marseille, 13009, France

Location

CHU de Nantes hotel Dieu

Nantes, 44000, France

Location

Hopital St Louis

Paris, 75475, France

Location

CHU de Bordeaux - Hospital Haut-Leveque

Pessac, 33600, France

Location

Gustave Roussy

Villejuif, 94800, France

Location

Pratia MCM Krakow

Krakow, 30-727, Poland

Location

Centrum Medyczne Pratia Poznan

Skorzewo, 60 185, Poland

Location

Universitetssjukhuset Lund, Onkologiska Kliniken, Lund

Lund, 221 85, Sweden

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLymphoma, Non-Hodgkin

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2021

First Posted

May 6, 2021

Study Start

July 28, 2021

Primary Completion

February 13, 2025

Study Completion

February 13, 2025

Last Updated

August 21, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

More information

Locations

SE(1)PL(2)DK(1)FR(6)