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| ID | Type | Description | Link |
|---|---|---|---|
| 67856633LYM1002 | Other Identifier | Janssen Research & Development, LLC | |
| 2021-000191-12 | EudraCT Number | ||
| 2024-512689-32-00 | Registry Identifier | EUCT number |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-67856633 | Drug | Participants will receive JNJ-67856633 orally. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of JNJ-67856633 and Ibrutinib | Plasma samples will be analyzed to determine concentrations of JNJ-67856633 and Ibrutinib. | Up to 2 years and 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark | |||
| CHRU de Lille Hopital Claude Huriez |
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
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| Ibrutinib |
| Drug |
Participants will receive Ibrutinib orally. |
|
|
| Lille |
| 59037 |
| France |
| Institut Paoli Calmettes | Marseille | 13009 | France |
| CHU de Nantes hotel Dieu | Nantes | 44000 | France |
| Hopital St Louis | Paris | 75475 | France |
| CHU de Bordeaux - Hospital Haut-Leveque | Pessac | 33600 | France |
| Gustave Roussy | Villejuif | 94800 | France |
| Pratia MCM Krakow | Krakow | 30-727 | Poland |
| Centrum Medyczne Pratia Poznan | Skorzewo | 60 185 | Poland |
| Universitetssjukhuset Lund, Onkologiska Kliniken, Lund | Lund | 221 85 | Sweden |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
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| ID | Term |
|---|---|
| C551803 | ibrutinib |
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