A Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in B-cell NHL and CLL
- Conditions
- Leukemia, Lymphocytic, Chronic, B-CellLymphoma, Non-Hodgkin
- Interventions
- Registration Number
- NCT04876092
- Lead Sponsor
- Janssen Research & Development, LLC
- 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).
- Detailed Description
Non-Hodgkin lymphoma (NHL) represents the most frequent hematologic malignancy in the world and represents a diverse set of diseases. JNJ-67856633-ZAF (referred as JNJ-67856633) is an orally bioavailable, potent, and selective first-in-class mucosa-associated lymphoid tissue lymphoma translocation protein-1 (MALT1) inhibitor. JNJ-67856633 binds to an allosteric site on MALT1 with a mixed-type mechanism. Ibrutinib is a first-in-class, orally administered, potent, orally administered covalently binding small-molecule inhibitor of Bruton's tyrosine kinase (BTK), as well as interleukin-2-inducible kinase (ITK), a tyrosine protein (Tec) kinase family member present in T cells. The doses will be escalated in the study and one or more recommended Phase 2 dose (RP2Ds) of JNJ-67856633 will be determined. The study is divided into 3 periods: a screening phase, a treatment phase, and a post-treatment follow-up phase. Efficacy assessments will include radiographic image assessments, positron emission tomography scan, bone marrow assessment, endoscopy etc. Safety assessment like physical examination, vital signs, electrocardiogram (ECG), eastern cooperative oncology group (ECOG) performance status, and adverse events monitoring will be performed during the study. Total duration of the study will be up to 2 years and 9 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description JNJ-67856633 and Ibrutinib JNJ-67856633 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). JNJ-67856633 and Ibrutinib Ibrutinib 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).
- Primary Outcome Measures
Name Time Method Percentage of Participants with Dose-Limiting Toxicity (DLT) Up to 21 days 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.
Percentage of Participants with Adverse Events (AEs) by Severity Up to 2 years and 9 months Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
- Secondary Outcome Measures
Name Time Method Plasma Concentration of JNJ-67856633 and Ibrutinib Up to 2 years and 9 months Plasma samples will be analyzed to determine concentrations of JNJ-67856633 and Ibrutinib.
Related Research Topics
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Trial Locations
- Locations (10)
Institut Paoli Calmettes
🇫🇷Marseille, France
Hopital St Louis
🇫🇷Paris, France
Rigshospitalet
🇩🇰Copenhagen, Denmark
CHU de Nantes hotel Dieu
🇫🇷Nantes, France
CHRU de Lille Hopital Claude Huriez
🇫🇷Lille, France
Gustave Roussy
🇫🇷Villejuif Cedex, France
CHU de Bordeaux - Hospital Haut-Leveque
🇫🇷Pessac, France
Universitetssjukhuset Lund, Onkologiska Kliniken, Lund
🇸🇪Lund, Sweden
Pratia MCM Krakow
🇵🇱Krakow, Poland
Centrum Medyczne Pratia Poznan
🇵🇱Skorzewo, Poland