A Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in B-cell NHL and CLL
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| ClinicalTrials.gov Identifier: NCT04876092 |
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Recruitment Status :
Recruiting
First Posted : May 6, 2021
Last Update Posted : February 25, 2022
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Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
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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) in Part A (Dose Escalation) and to evaluate safety of JNJ-67856633 and ibrutinib in combination, at the RP2D regimen in Part B (Cohort Expansion).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Non-Hodgkin | Drug: JNJ-67856633 Drug: Ibrutinib | Phase 1 |
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 study will be conducted in 2 parts: Part A (Dose Escalation) and Part B (Expansion Phase). In dose escalation phase, one or more recommended Phase 2 dose (RP2Ds) of JNJ-67856633 will be determined. After the RP2D(s) is determined in the dose escalation phase, expansion phase will be conducted. 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 6 months.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | N/A |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1b Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in Relapsed or Refractory B Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia |
| Actual Study Start Date : | July 28, 2021 |
| Estimated Primary Completion Date : | February 21, 2023 |
| Estimated Study Completion Date : | January 29, 2024 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Ibrutinib
| Arm | Intervention/treatment |
|---|---|
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Experimental: JNJ-67856633 and Ibrutinib
Participants in Part A (dose escalation) 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) until the recommended Phase 2 Doses (RP2Ds) has been identified. Participants in Part B (cohort expansion) will receive JNJ-67856633 together with Ibrutinib orally at one of the RP2D(s) determined in Part A.
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Drug: JNJ-67856633
Participants will receive JNJ-67856633 orally. Drug: Ibrutinib Participants will receive Ibrutinib orally.
Other Name: JNJ-54179060 |
Primary Outcome Measures :
- Percentage of Participants with Dose-Limiting Toxicity (DLT) [ Time Frame: 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 [ Time Frame: Up to 2 years and 6 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 :
- Part A and B: Plasma Concentration of JNJ-67856633 and Ibrutinib [ Time Frame: Up to 2 years and 6 months ]Plasma samples will be analyzed to determine concentrations of JNJ-67856633 and Ibrutinib.
- Part B: Duration of Response (DOR) [ Time Frame: Up to 2 years and 6 months ]DOR is defined for participants who achieved PR, MaRR or CR as the time between the date of initial documentation of such responses to the date of either the first documented evidence of relapse or death. For participants who have not relapsed or died, data will be censored at the last disease evaluation.
- Part B: Time to First Response (TTR) [ Time Frame: Up to 2 years and 6 months ]TTR is defined for participants who achieved PR, MaRR, or CR as the time from the first dose of study drug to first of such responses.
- Part B: Overall Response Rate (ORR) [ Time Frame: Up to 2 years and 6 months ]ORR is defined as the percentage of participants who have a partial response (PR) and complete response (CR) according to Non-Hodgkin Lymphoma (NHL), International Workshop on Chronic Lymphocytic Leukemia (iwCLL) and Waldenstrom macroglobulinemia (WM) response criteria.
- Part B: Complete Response Rate [ Time Frame: Up to 2 years and 6 months ]Complete response rate is defined as the percentage of participants who achieve a best response of CR according to the iwCLL, NHL and WM response criteria.
- Part B: Major Response Rate (MaRR) [ Time Frame: Up to 2 years and 6 months ]MaRR (PR+ very good partial response [VGPR]) rate is defined as the percentage of participants who achieve a best response of PR or VGPR according to NHL, iwCLL and WM response criteria.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04876092
Contacts
| Contact: Study Contact | 844-434-4210 | JNJ.CT@sylogent.com |
Locations
Show 34 study locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Additional Information:
| Responsible Party: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT04876092 |
| Other Study ID Numbers: |
CR109010 2021-000191-12 ( EudraCT Number ) 67856633LYM1002 ( Other Identifier: Janssen Research & Development, LLC ) |
| First Posted: | May 6, 2021 Key Record Dates |
| Last Update Posted: | February 25, 2022 |
| Last Verified: | February 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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 |
| URL: | https://www.janssen.com/clinical-trials/transparency |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Lymphoma Leukemia Lymphoma, Non-Hodgkin Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell |