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NCT03900598CompletedPhase 1

A Study of JNJ-67856633 in Participants With Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

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

Source: ClinicalTrials.gov · Last updated 22 Jun 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
226 (actual)
First submitted
2 Apr 2019
Start date
3 Apr 2019
Primary completion date
22 May 2025
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT03900598
EU CT number
2024-512734-15-00
EudraCT number
2018-003549-40

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 226
  • From 3 Apr 2019 to the primary completion date, 22 May 2025
  • 41 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • 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

Other

  • Known active central nervous system (CNS) involvement for dose escalation and specific expansion cohorts as determined by the study evaluation team (SET)

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (41)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Monash Medical Centre
Coordinator of this site? Confirm its status
ClaytonAustraliaUnknown status
Peter MacCallum Cancer Centre
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MelbourneAustraliaUnknown status
Linear Clinical Research Ltd
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NedlandsAustraliaUnknown status
Scientia Clinical Research
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RandwickAustraliaUnknown status
The First Affiliated Hospital of NanChang University
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NanchangChinaUnknown status
Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
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TianjinChinaUnknown status
Tianjin Medical University Cancer Institute and Hospital
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TianjinChinaUnknown status
The First Affiliated Hospital of Xian Jiaotong University
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Xi'anChinaUnknown status
Universitätsklinikum Münster
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MünsterGermanyUnknown status
Universitätsklinikum Ulm
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UlmGermanyUnknown status
Hosp. Univ. Germans Trias I Pujol
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BadalonaSpainUnknown status
Hospital de Vall D'Hebron
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BarcelonaSpainUnknown status
Hosp. Univ. 12 de Octubre
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MadridSpainUnknown status
Hosp Univ Fund Jimenez Diaz
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MadridSpainUnknown status
Clinica Univ. de Navarra
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PamplonaSpainUnknown status
Hosp. Quiron Madrid Pozuelo
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Pozuelo de AlarcónSpainUnknown status
Hosp Clinico Univ de Salamanca
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SalamancaSpainUnknown status
Hosp. Univ. Marques de Valdecilla
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SantanderSpainUnknown status
Centre Hospitalier Universitaire de Lille
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LilleFranceCompleted
Hospices Civils de Lyon
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Pierre-BéniteFranceCompleted
St. Bartholomew's Hospital
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LondonUnited KingdomUnknown status
Alexandra Hospital
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AthensGreeceCompleted
Hadassah medical Center
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JerusalemIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelUnknown status
Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna
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BolognaItalyUnknown status
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyUnknown status
National Cancer Center Hospital
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ChūōkuJapanUnknown status
Tokai University Hospital
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IseharaJapanUnknown status
National Hospital Organization Nagoya Medical Center
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NagoyaJapanUnknown status
Okayama University Hospital
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OkayamaJapanUnknown status
The Cancer Institute Hospital of JFCR
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TokyoJapanUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
City of Hope
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DuarteUnited StatesUnknown status
MD Anderson
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HoustonUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai
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New YorkUnited StatesUnknown status
Weill Cornell Medicine
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New YorkUnited StatesUnknown status
University of Nebraska Medical Center
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OmahaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.