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

Completed · Phase 1

Conditions studied: Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin

In brief

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.

Key facts

Study ID

NCT03900598

Run by

Janssen Research & Development, LLC

People needed

226

Starts

2019-04-03

Expected to finish

2025-05-22

Last updated by the study team

2025-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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