Non Hodgkin Lymphoma Clinical Trial

A Study of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

Summary

The purpose of the study is to determine the recommended Phase 2 dose(s) (RP2D[s]) in B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) in Part 1 and to evaluate the safety of JNJ-64264681 at the RP2D(s) in Part 2.

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Eligibility Criteria

Inclusion Criteria:

Participants must have Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
Participants must have cardiac parameters within the following range: corrected QT interval (QTcF) less than or equal to <= 480 milliseconds based on the average of triplicate assessments performed as close as possible in succession (the full set of triplicates should be completed in less than 10 minutes)
Women of childbearing potential must have a negative highly sensitive serum pregnancy test (example: beta human chorionic gonadotropin [beta-hCG]) at screening, and a negative serum or urine pregnancy test prior to the first dose of study drug
Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of at least 30 days after the last study drug administration
Participants must be willing and able to adhere to the lifestyle restrictions specified in this protocol

Exclusion Criteria:

Participant has known active central nervous system (CNS) involvement
Participant has received prior solid organ transplantation
Participant has known allergies, hypersensitivity, or intolerance to JNJ-64264681 or its excipients
Participant has been treated with an investigational drug (including investigational vaccines) within five half-lives or 2 weeks before the planned first dose of study drug
Participant is experiencing toxicities from previous anticancer therapies that have not resolved to baseline levels, or to Grade 1 or less (except for alopecia and peripheral neuropathy)

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

108

Study ID:

NCT04210219

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 16 Locations for this study

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Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Arensia Exploratory Medicine
Tbilisi , 0112, Georgia
Arensia Exploratory Medicine
Chisinau , MD-20, Moldova, Republic of
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-21, Poland
Pratia Onkologia Katowice
Katowice , 40-51, Poland
Pratia MCM Krakow
Krakow , 30-51, Poland
Centrum Medyczne Pratia Poznan
Skorzewo , 60-18, Poland
Chang-Gung Memorial Hospital, Kaohsiung
Kaohsiung County , 83301, Taiwan
China Medical University Hospital
Taichung , 40402, Taiwan
Taichung Veterans General Hospital
Taichung , 40705, Taiwan
National Cheng Kung University Hospital
Tainan , 70403, Taiwan
National Taiwan University Hospital
Taipei , 10048, Taiwan
Medical Center of Limited Liability Company Arensia Exploratory Medicine
Kiev , 1135, Ukraine
Queen Mary University of London
Charterhouse Square , EC1M , United Kingdom
St James University Hospital
Leeds , LS9 7, United Kingdom
Plymouth Hospitals NHS Trust
Plymouth , PL6 8, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

108

Study ID:

NCT04210219

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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