A Study of JNJ-67856633 in Participants With Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
NCT ID: NCT03900598
Last Updated: 2025-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
226 participants
INTERVENTIONAL
2019-04-03
2025-05-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
JNJ-67856633
JNJ-67856633 capsule will be administered orally.
Part 2 (Cohort Expansion): JNJ-67856633
Participants will receive JNJ-67856633 at the recommended Phase 2 dose (RP2D) determined in Part 1.
JNJ-67856633
JNJ-67856633 capsule will be administered orally.
Interventions
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JNJ-67856633
JNJ-67856633 capsule will be administered orally.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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City of Hope
Duarte, California, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Weill Cornell Medicine
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
MD Anderson
Houston, Texas, United States
Monash Medical Centre
Clayton, , Australia
Peter MacCallum Cancer Centre
Melbourne, , Australia
Linear Clinical Research Ltd
Nedlands, , Australia
Scientia Clinical Research
Randwick, , Australia
The First Affiliated Hospital of NanChang University
Nanchang, , China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, , China
Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
Tianjin, , China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, , China
Hopital Claude Huriez
Lille, , France
CHU de Nantes hotel Dieu
Nantes, , France
Groupe Hospitalier Pitie Salpetriere
Paris, , France
Institut Curie
Paris, , France
Centre hospitalier Lyon-Sud
Pierre-Bénite, , France
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, , France
CHU Bretonneau
Tours, , France
Institut Gustave Roussy
Villejuif, , France
Universitatsklinikum Munster
Münster, , Germany
Universitatsklinikum Ulm
Ulm, , Germany
Alexandra General Hospital of Athens
Athens, , Greece
Hadassah Medical Center
Jerusalem, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna
Bologna, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
National Cancer Center Hospital
Chūōku, , Japan
Tokai University Hospital
Isehara, , Japan
National Hospital Organization Nagoya Medical Center
Nagoya, , Japan
Okayama University Hospital
Okayama, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hosp. Univ. Germans Trias I Pujol
Badalona, , Spain
Hospital de Vall D'Hebron
Barcelona, , Spain
Hosp Univ Fund Jimenez Diaz
Madrid, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Clinica Univ. de Navarra
Pamplona, , Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, , Spain
Hosp Clinico Univ de Salamanca
Salamanca, , Spain
Hosp. Univ. Marques de Valdecilla
Santander, , Spain
St Bartholomew's Hospital
London, , United Kingdom
Countries
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Other Identifiers
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67856633LYM1001
Identifier Type: OTHER
Identifier Source: secondary_id
2018-003549-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-512734-15-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR108587
Identifier Type: -
Identifier Source: org_study_id
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