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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04657224




Registration number
NCT04657224
Ethics application status
Date submitted
1/12/2020
Date registered
8/12/2020

Titles & IDs
Public title
A Study of JNJ-64264681 and JNJ-67856633 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
Scientific title
A Phase 1b, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64264681 in Combination With JNJ-67856633 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
Secondary ID [1] 0 0
2020-003149-12
Secondary ID [2] 0 0
CR108877
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma, Non-Hodgkin 0 0
Chronic Lymphocytic Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-64264681
Treatment: Drugs - JNJ-67856633

Experimental: Part A: Dose escalation: JNJ-64264681 and JNJ-67856633 - Participants will receive JNJ-64264681 and JNJ-67856633 will be administered together until disease progression, intolerable toxicity, withdrawal of consent, or the investigator.

Experimental: Part B: Cohort Expansion: JNJ-64264681 and JNJ-67856633 - Participants will receive JNJ-64264681 and JNJ-67856633 at the recommended Phase 2 dose (RP2D) determined in Part 1.


Treatment: Drugs: JNJ-64264681
JNJ-64264681 capsules will be administered orally.

Treatment: Drugs: JNJ-67856633
JNJ-67856633 capsules or tablets will be administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A: Number of Participants with Dose-limiting Toxicity (DLT)
Timepoint [1] 0 0
Up to 28 days
Primary outcome [2] 0 0
Part A and Part B: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Timepoint [2] 0 0
Up to 3 years and 9 months
Secondary outcome [1] 0 0
Plasma Concentrations of JNJ-64264681 and JNJ-67856633
Timepoint [1] 0 0
Up to 3 years and 9 months
Secondary outcome [2] 0 0
Bruton's Tyrosine Kinase (BTK) Occupancy in Peripheral Blood Mononuclear Cell (PBMCs)
Timepoint [2] 0 0
Up to 3 years and 9 months
Secondary outcome [3] 0 0
Overall Response Rate (ORR)
Timepoint [3] 0 0
Up to 3 years and 9 months
Secondary outcome [4] 0 0
Time to First Response
Timepoint [4] 0 0
Up to 3 years and 9 months
Secondary outcome [5] 0 0
Duration of Response
Timepoint [5] 0 0
Up to 3 years and 9 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/07/2025
Actual
Sample size
Target
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment hospital [4] 0 0
Scientia Clinical Research - Randwick
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
Belgium
State/province [2] 0 0
Brugge
Country [3] 0 0
Belgium
State/province [3] 0 0
Gent
Country [4] 0 0
Belgium
State/province [4] 0 0
Yvoir
Country [5] 0 0
France
State/province [5] 0 0
Lille
Country [6] 0 0
France
State/province [6] 0 0
Nantes Cedex 1
Country [7] 0 0
France
State/province [7] 0 0
Pierre Benite
Country [8] 0 0
France
State/province [8] 0 0
Tours Cedex 9
Country [9] 0 0
Georgia
State/province [9] 0 0
Tbilisi
Country [10] 0 0
Israel
State/province [10] 0 0
Jerusalem
Country [11] 0 0
Israel
State/province [11] 0 0
Ramat Gan
Country [12] 0 0
Israel
State/province [12] 0 0
Tel Aviv
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Seoul
Country [14] 0 0
Moldova, Republic of
State/province [14] 0 0
Chisinau
Country [15] 0 0
Netherlands
State/province [15] 0 0
Amsterdam
Country [16] 0 0
Poland
State/province [16] 0 0
Gdansk
Country [17] 0 0
Poland
State/province [17] 0 0
Katowice
Country [18] 0 0
Poland
State/province [18] 0 0
Krakow
Country [19] 0 0
Poland
State/province [19] 0 0
Skorzewo
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid
Country [22] 0 0
Ukraine
State/province [22] 0 0
Kiev

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trials
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04657224