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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03900598




Registration number
NCT03900598
Ethics application status
Date submitted
2/04/2019
Date registered
3/04/2019
Date last updated
15/08/2019

Titles & IDs
Public title
A Study of JNJ-67856633 in Participants With Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
Scientific title
A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-67856633, an Inhibitor of MALT1, in Participants With NHL and CLL
Secondary ID [1] 0 0
2018-003549-40
Secondary ID [2] 0 0
CR108587
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Lymphocytic, Chronic, B-Cell 0 0
Lymphoma, Non-Hodgkin 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-67856633

Experimental: Part 1 (Dose Escalation): JNJ-67856633 - Participants will receive JNJ-67856633 until disease progression, intolerable toxicity, withdrawal of consent, or the investigator or sponsor decision. Subsequent dose levels will be assigned by the sponsor using an adaptive dose escalation strategy based on all available safety, pharmacokinetic (PK), and biomarker data.

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


Treatment: Drugs: JNJ-67856633
JNJ-67856633 capsule will be administered orally.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Dose-Limiting Toxicity (DLT) - The DLTs are based on drug related adverse events and defined as any of the following events: any toxicity that would require discontinuation of treatment; and/or hematological / non-hematological toxicity of Grade 3 or higher.
Timepoint [1] 0 0
Approximately 21 days
Primary outcome [2] 0 0
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability - An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Timepoint [2] 0 0
Approximately 2 years
Secondary outcome [1] 0 0
JNJ-67856633 Plasma Concentrations - Concentration assessment will be done to evaluate the effect of JNJ-67856633.
Timepoint [1] 0 0
Approximately 2 years
Secondary outcome [2] 0 0
Part 1 and Part 2: Change in Gene Expression After Treatment with JNJ-67856633 - Change in gene expression after treatment with JNJ-67856633 will be analyzed.
Timepoint [2] 0 0
Approximately 2 years
Secondary outcome [3] 0 0
Part 1 and Part 2: Overall Response Rate (ORR) - ORR is defined as the percentage of participants who have a partial response (PR) and complete response (CR) according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL), non-Hodgkin lymphoma and Waldenstrom macroglobulinemia response criteria.
Timepoint [3] 0 0
Approximately 2 years
Secondary outcome [4] 0 0
Part 1 and Part 2: Complete Response Rate - Complete response rate is defined as the percentage of participants who achieve a best response of CR according to the iwCLL, non-Hodgkin lymphoma and Waldenstrom macroglobulinemia response criteria.
Timepoint [4] 0 0
Approximately 2 years
Secondary outcome [5] 0 0
Part 1 and Part 2: Time to Response (TTR) - TTR is defined for participants who achieved PR or CR as the time from the first dose of study drug to first response of PR or CR.
Timepoint [5] 0 0
Approximately 2 years
Secondary outcome [6] 0 0
Part 1 and Part 2: Duration of Response (DoR) - DoR is defined for participants who achieved PR or CR as the time between the date of initial documentation of PR or CR to the date of first documented evidence of disease progression or death, whichever comes first.
Timepoint [6] 0 0
Approximately 2 years

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 (QTc intervals
corrected using Fridericia's formula [QTcF]) less than or equal to (<=)480
milliseconds based on the average of triplicate assessments performed no more than 5
minutes apart (plus minus [+-]3 minutes)

- Women of childbearing potential must have a negative highly sensitive serum (Beta
human chorionic gonadotropin) at screening and prior to the first dose of study drug

- In addition to the user-independent, highly effective method of contraception, a male
or female condom with or without spermicide is required, example, condom with
spermicidal foam/gel/film/cream/suppository. Male condom and female condom should not
be used together (due to risk of failure with friction)

- Men must wear a condom when engaging in any activity that allows for passage of
ejaculate to another person. Male participants should also be advised of the benefit
for a female partner to use a highly effective method of contraception as condom may
break or leak
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known central nervous system (CNS) involvement for dose escalation and specific
expansion cohorts as determined by the study evaluation team (SET)

- Prior solid-organ transplantation

- Either of the following: a) Received an autologous stem cell transplant less than or
equal to (<=)3 months before the first dose of study drug. b) Prior treatment with
allogenic stem cell transplant <=6 months before the first dose of study drug, has
evidence of graft versus host disease, or requires immunosuppressant therapy

- History of malignancy (other than the disease under study in the cohort to which the
participant is assigned) within 3 years prior to the first administration of study
drug (for participants in the cohort expansions). Exceptions are squamous and basal
cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy which
in the opinion of the investigator, with concurrence with the sponsor's medical
monitor, is considered cured with minimal risk of recurrence within 3 years before the
first dose of study drug. Participants on active treatment for other progressive
malignancies other than those being studied in the cohort to which the participant has
been assigned will be excluded in both parts of the study

- Prior treatment with a mucosa-associated lymphoid tissue lymphoma translocation
protein 1 (MALT1) inhibitor

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
France
State/province [2] 0 0
Lille
Country [3] 0 0
France
State/province [3] 0 0
Paris
Country [4] 0 0
France
State/province [4] 0 0
Pierre Benite
Country [5] 0 0
France
State/province [5] 0 0
Tours Cedex 9
Country [6] 0 0
Germany
State/province [6] 0 0
Münster
Country [7] 0 0
Israel
State/province [7] 0 0
Tel Aviv
Country [8] 0 0
Spain
State/province [8] 0 0
Barcelona
Country [9] 0 0
Spain
State/province [9] 0 0
Madrid
Country [10] 0 0
Spain
State/province [10] 0 0
Salamanca

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the recommended Phase 2 dose regimen or the maximum
tolerated dose of JNJ-67856633 in participants with relapsed/ refractory B-cell non-Hodgkin
lymphoma and chronic lymphocytic leukemia.
Trial website
https://clinicaltrials.gov/show/NCT03900598
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
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
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
JNJ.CT@sylogent.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03900598