A Study of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
NCT ID: NCT04210219
Last Updated: 2025-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
85 participants
INTERVENTIONAL
2020-07-02
2025-05-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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JNJ-64264681: Dose Escalation and Expansion
Participants will receive oral administration of JNJ-64264681 capsule at a dose assigned by the sponsor Study Evaluation Team (SET), based on the available safety, pharmacokinetics, and pharmacodynamics data in dose escalation treatment group (Part 1); and recommended Phase 2 dose (RP2D) determined in Part 1 in cohort expansion treatment group (Part 2).
JNJ-64264681
JNJ-64264681 capsule will be administered orally.
Interventions
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JNJ-64264681
JNJ-64264681 capsule will be administered orally.
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, United States
Arensia Exploratory Medicine
Tbilisi, , Georgia
Arensia Exploratory Medicine
Chisinau, , Moldova
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Pratia Onkologia Katowice
Katowice, , Poland
Pratia MCM Krakow
Krakow, , Poland
Centrum Medyczne Pratia Poznan
Skorzewo, , Poland
Chang-Gung Memorial Hospital, Kaohsiung
Kaohsiung County, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Medical Center of Limited Liability Company Arensia Exploratory Medicine
Kyiv, , Ukraine
Queen Mary University of London
Charterhouse Square, , United Kingdom
Plymouth Hospitals NHS Trust
Plymouth, , United Kingdom
Countries
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Other Identifiers
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64264681LYM1001
Identifier Type: OTHER
Identifier Source: secondary_id
2019-003194-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-512686-13-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR108706
Identifier Type: -
Identifier Source: org_study_id
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