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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03900598
Registration number
NCT03900598
Ethics application status
Date submitted
2/04/2019
Date registered
3/04/2019
Date last updated
23/05/2024
Titles & IDs
Public title
A Study of JNJ-67856633 in Participants With Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
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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
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Secondary ID [1]
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2018-003549-40
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Secondary ID [2]
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CR108587
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Leukemia, Lymphocytic, Chronic, B-Cell
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Lymphoma, Non-Hodgkin
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1: Dose-Limiting Toxicity (DLT)
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Assessment method [1]
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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.
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Timepoint [1]
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Approximately 21 days
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Primary outcome [2]
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Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 4 years and 11 months
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Secondary outcome [1]
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JNJ-67856633 Plasma Concentrations
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Assessment method [1]
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Concentration assessment will be done to evaluate the effect of JNJ-67856633.
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Timepoint [1]
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Up to 4 years and 11 months
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Secondary outcome [2]
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Part 1 and Part 2: Overall Response Rate (ORR)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 4 years and 11 months
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Secondary outcome [3]
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Part 1 and Part 2: Complete Response Rate
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Assessment method [3]
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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.
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Timepoint [3]
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Up to 4 years and 11 months
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Secondary outcome [4]
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Part 1 and Part 2: Time to Response (TTR)
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 4 years and 11 months
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Secondary outcome [5]
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Part 1 and Part 2: Duration of Response (DoR)
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Assessment method [5]
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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.
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Timepoint [5]
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Up to 4 years and 11 months
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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,
and until 30 days after the last dose
- 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Known active 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 for graft
versus host disease within the last 4 weeks
- History of malignancy (other than the disease under study in the cohort to which the
participant is assigned) within 1 year prior to the first administration of study
drug. 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 1 year before the first dose of study drug. Concomitant
malignancies that are unlikely to progress and/or preclude evaluation of study
endpoints may be allowed after discussion with the Study Responsible Physician
- Prior treatment with a mucosa-associated lymphoid tissue lymphoma translocation
protein 1 (MALT1) inhibitor
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/04/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/01/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
226
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Monash Medical Centre - Clayton
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Recruitment hospital [2]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [3]
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Linear Clinical Research Ltd - Nedlands
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Recruitment hospital [4]
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Scientia Clinical Research - Randwick
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment postcode(s) [4]
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2031 - Randwick
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Nebraska
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United States of America
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New York
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United States of America
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Texas
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China
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Nanchang
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China
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Tianjin
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China
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Xi'an
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France
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Lille
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France
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State/province [9]
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Nantes Cedex 1
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France
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State/province [10]
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PARIS Cedex 5
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France
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Paris
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France
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Pierre Benite
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France
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Toulouse
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France
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State/province [14]
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Tours Cedex 9
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France
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VILLEJUIF Cedex
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Germany
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Münster
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Germany
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Ulm
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Greece
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Athens
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Israel
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Jerusalem
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Bologna
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Italy
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Milano
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Japan
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Chuo Ku
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Japan
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Isehara
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Japan
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Nagoya-shi
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Japan
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Okayama
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Japan
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Tokyo
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Korea, Republic of
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Seoul
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Spain
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Badalona, Barcelona
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Pamplona
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Spain
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Pozuelo de Alarcon
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Spain
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Salamanca
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Spain
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Santander
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Country [37]
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United Kingdom
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State/province [37]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03900598
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03900598
Download to PDF