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.
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)
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There are 16 Locations for this study
New York New York, 10029, United States
Tbilisi , 0112, Georgia
Chisinau , MD-20, Moldova, Republic of
Gdansk , 80-21, Poland
Katowice , 40-51, Poland
Krakow , 30-51, Poland
Skorzewo , 60-18, Poland
Kaohsiung County , 83301, Taiwan
Taichung , 40402, Taiwan
Taichung , 40705, Taiwan
Tainan , 70403, Taiwan
Taipei , 10048, Taiwan
Kiev , 1135, Ukraine
Charterhouse Square , EC1M , United Kingdom
Leeds , LS9 7, United Kingdom
Plymouth , PL6 8, United Kingdom
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