Non Hodgkin Lymphoma Clinical Trial

A Study of JNJ-64264681 and JNJ-67856633 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

Summary

The primary purpose of this study is to determine: the recommended Phase 2 doses (RP2Ds) of JNJ-64264681 and JNJ 67856633 when administered together in participants with B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) (Part A - Dose Escalation); and the safety of the RP2Ds for this combination in different histologies/participant populations (Part B - Cohort Expansion).

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Full Description

Bruton's tyrosine kinase (BTK) is a cytoplasmic tyrosine kinase that plays a critical role in B cell activation via the B cell receptor (BCR) signaling pathway. BTK is important for normal B-cell activation and the pathophysiology of B cell malignancies. A few BTK inhibitors have demonstrated clinical activity in non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Non-Hodgkin lymphoma represents a diverse set of diseases, of which more than 60 subtypes have been identified and classified by the world health organization. JNJ-64264681 is a second-generation, orally active, selective, and irreversible covalent inhibitor of BTK and JNJ-67856633 is an orally bioavailable, potent, and selective first in class mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1) inhibitor that binds to an allosteric site on MALT1 with a mixed-type mechanism. JNJ-64264681 and JNJ-67856633 inhibit BTK and MALT1, respectively, and both BTK and MALT1 are involved in transmitting the pro-survival BCR signal. The study will consist of Screening Phase (28 days); Treatment Phase (from Cycle 1 Day 1 up to end of treatment, each cycle is a 21-day cycle) and a Follow-up Phase (from end of treatment visit until lost to follow-up, withdrawal of consent, death, 6 months after start of first subsequent antineoplastic therapy). The total study duration is estimated at 2 years and 2 months. Safety assessments will include physical examinations, vital signs, electrocardiograms, clinical safety laboratory assessments, eastern cooperative oncology group performance status, echocardiogram, and adverse events monitoring.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
Cardiac parameters within the following range: corrected QT interval (QTcF) <= 480 milliseconds
Participants with B cell non-Hodgkin lymphoma (NHL) must have tumor tissue available at baseline as described in the protocol. This is not required for participants with chronic lymphocytic leukemia (CLL)
Women of childbearing potential must agree to use a barrier method of contraception; use a highly effective preferably user-independent method of contraception; not to donate eggs (ova, oocytes) or freeze them for future use for the purposes of assisted reproduction during the study; not to plan to become pregnant; and not to breast-feed

Exclusion Criteria:

Part A and select cohorts in Part B: Prior treatment with JNJ 64264681 or JNJ-67856633. Previously discontinued treatment with a Bruton's tyrosine kinase (BTK) or mucosa-associated lymphoid tissue lymphoma translocation protein (MALT) inhibitor other than JNJ 64264681 or JNJ-67856633 due to participant or doctor choice without evidence of progression or intolerable class-related toxicity will be eligible
Known (active) central nervous system (CNS) involvement
Received prior solid organ transplantation
Participant has known allergies, hypersensitivity, or intolerance to JNJ-64264681 or JNJ 67856633 or excipients
Toxicities from previous anti-cancer therapies that have not resolved to baseline levels, or to Grade less than (<) 2 (except for alopecia [>=Grade 2], vitiligo [Grade 2] and peripheral neuropathy [Grade 1])

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

75

Study ID:

NCT04657224

Recruitment Status:

Active, not recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 28 Locations for this study

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Stony Brook University Medical Center
Stony Brook New York, 11794, United States
Monash Medical Centre
Clayton , 3168, Australia
Peter MacCallum Cancer Centre
Melbourne , 3000, Australia
Linear Clinical Research Ltd
Nedlands , 6009, Australia
Scientia Clinical Research
Randwick , 2031, Australia
AZ St.-Jan Brugge-Oostende AV
Brugge , 8000, Belgium
Universitair Ziekenhuis Gent - UZ GENT
Gent , 9000, Belgium
CHU UCL Namur - Site Godinne
Yvoir , 5530, Belgium
CHRU de Lille - Hôpital Claude Huriez
Lille , 59037, France
Chu Hotel Dieu
Nantes Cedex 1 , 44093, France
Centre hospitalier Lyon-Sud
Pierre Benite , 69495, France
CHU Bretonneau
Tours Cedex 9 , 37044, France
Arensia Exploratory Medicine
Tbilisi , 0112, Georgia
Hadassah Medical Center
Jerusalem , 91120, Israel
Sheba Medical Center
Ramat Gan , 52621, Israel
Tel Aviv Sourasky MC
Tel Aviv , 64239, Israel
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Seoul National University Hospital
Seoul , 3080, Korea, Republic of
Arensia Exploratory Medicine
Chisinau , Md202, Moldova, Republic of
Academic Medical Center
Amsterdam , 1105 , Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-21, Poland
Pratia Onkologia Katowice
Katowice , 40-51, Poland
Pratia MCM Krakow
Krakow , 30-51, Poland
Centrum Medyczne Pratia Poznan
Skorzewo , 60-18, Poland
Hosp. Univ. Vall D Hebron
Barcelona , 08035, Spain
Hosp. Univ. Fund. Jimenez Diaz
Madrid , 28040, Spain
Medical Center of Limited Liability Company Arensia Exploratory Medicine
Kiev , 1135, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

75

Study ID:

NCT04657224

Recruitment Status:

Active, not recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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