A Phase 1, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

  • STATUS
    Recruiting
  • End date
    Dec 12, 2024
  • participants needed
    108
  • sponsor
    Janssen Research & Development, LLC
Updated on 23 October 2022
lymphoid leukemia
chronic lymphocytic leukemia
lymphoma
hodgkin's disease
leukemia
beta human chorionic gonadotrophin

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.

Details
Condition Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
Treatment JNJ-64264681
Clinical Study IdentifierNCT04210219
SponsorJanssen Research & Development, LLC
Last Modified on23 October 2022

Eligibility

Yes No Not Sure

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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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