Non Hodgkin Lymphoma Clinical Trial

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

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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Full Description

Non-Hodgkin lymphoma (NHL) represents a diverse set of diseases. Among them diffuse large B-cell lymphoma (DLBCL) represents the most common subtype of NHL, accounting for 30 percent (%) to 40% of all newly diagnosed cases. Mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1) is a key mediator of the nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kappaB) signaling pathway and has been shown to play a critical role in different types of lymphoma, including activated B cell-like (ABC) subtype of diffuse large B-cell lymphoma (DLBCL). JNJ-67856633 is a MALT1 inhibitor and will be administered orally. The study will evaluate the following: Dose Escalation (Part 1): One or more recommended Phase 2 dose (RP2Ds) of JNJ-67856633. Cohort Expansion (Part 2): JNJ-67856633 is well tolerated and achieves antitumor responses at the RP2D. The study consists of screening phase (less than or equal to 28 days before first dose), treatment phase (from Cycle 1 Day 1 till end of treatment visit [within 30 (+7) days after the last dose]) and post-treatment phase. A prescreening period may also apply to participants in select cohorts in Part 2. The total study duration will be approximately 4 years and 11 months. Efficacy assessments will include radiographic image assessments, positron emission tomography scan, bone marrow assessment, endoscopy or colonoscopy etc. Safety will be monitored throughout the study.

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Eligibility Criteria

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

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

229

Study ID:

NCT03900598

Recruitment Status:

Active, not recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 46 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Weill Cornell Medicine
New York New York, 10021, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
MD Anderson
Houston Texas, 77025, United States
Monash Medical Centre
Clayton , 3168, Australia
Peter MacCallum Cancer Centre
Melbourne , 3000, Australia
Linear Clinical Research Ltd
Nedlands , 6009, Australia
Scientia Clinical Research
Randwick , 2031, Australia
The First Affiliated Hospital of NanChang University
Nanchang , 33000, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin , 30006, China
Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
Tianjin , 30032, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an , , China
Hopital Claude Huriez
Lille , 59037, France
CHU de Nantes hôtel-Dieu
Nantes Cedex 1 , 44093, France
Institut Curie
PARIS Cedex 5 , 75248, France
Groupe Hospitalier Pitie Salpetriere
Paris , 75013, France
Centre hospitalier Lyon-Sud
Pierre Benite , 69495, France
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse , 31059, France
CHU Bretonneau
Tours Cedex 9 , 37044, France
Institut Gustave Roussy
VILLEJUIF Cedex , 94805, France
Universitätsklinikum Münster
Münster , 48149, Germany
Universitätsklinikum Ulm
Ulm , 89081, Germany
Alexandra General Hospital of Athens
Athens , 11528, Greece
Hadassah Medical Center
Jerusalem , 91120, Israel
Sheba Medical Center
Ramat Gan , 74047, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna
Bologna , 40138, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milano , 20162, Italy
National Cancer Center Hospital
Chuo-Ku , 104-0, Japan
Tokai University Hospital
Isehara , 259-1, Japan
National Hospital Organization Nagoya Medical Center
Nagoya-shi , 460-0, Japan
Okayama University Hospital
Okayama , 700-8, Japan
The Cancer Institute Hospital of JFCR
Tokyo , 135-8, Japan
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Hosp. Univ. Germans Trias I Pujol
Badalona, Barcelona , 8916, Spain
Hospital de Vall D'Hebron
Barcelona , 08035, Spain
Hosp. Univ. Fund. Jimenez Diaz
Madrid , 28040, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain
Clinica Univ. de Navarra
Pamplona , 31008, Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcon , 28223, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca , 37007, Spain
Hosp. Univ. Marques de Valdecilla
Santander , 39008, Spain
St Bartholomew's Hospital
London , EC1A , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

229

Study ID:

NCT03900598

Recruitment Status:

Active, not recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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