A Study of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
- Conditions
- Lymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-Cell
- Interventions
- Drug: JNJ-64264681
- Registration Number
- NCT04210219
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 85
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description JNJ-64264681: Dose Escalation and Expansion JNJ-64264681 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).
- Primary Outcome Measures
Name Time Method Part 1: Number of Participants With Dose Limiting Toxicity (DLT) Up to 21 days The DLTs are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher (as specified in protocol).
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) Up to 2 years An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
- Secondary Outcome Measures
Name Time Method Plasma Concentration of JNJ-64264681 Up to 2 years Plasma concentration of JNJ-64264681 will be evaluated.
Percentage Occupancy of the Target Up to 2 years The pharmacodynamics of JNJ-64264681 will be assessed by determining the percentage of target occupancy. Blood samples will be obtained for pharmacodynamic assessments (target occupancy).
Overall Response Rate (ORR) Up to 2 years ORR is defined as the percentage of participants who achieve a complete response (CR) + partial response (PR) or better according to the Revised Response Criteria for Malignant Lymphoma and the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Response Criteria and International Workshop for Waldenstrom Macroglobulinemia (IWWM) Response Criteria.
Time to Response (TTR) Up to 2 years TTR is defined for participants who achieved PR or CR as the time from the first dose of study drug to first response of PR or CR according to the Revised Response Criteria for Malignant Lymphoma and iwCLL Response Criteria and IWWM Response Criteria.
Duration of Response (DOR) Up to 2 years DOR is defined for participants who achieved PR or CR as the time between the date of initial documentation of PR or CR to the date of either the first documented evidence of disease progression or death according to the Revised Response Criteria for Malignant Lymphoma and iwCLL Response Criteria and IWWM Response Criteria.
Complete Response (CR) Rate Up to 2 years CR rate is defined as the percentage of participants who achieve a best response of CR according to the Revised Response Criteria for Malignant Lymphoma and iwCLL Response Criteria and IWWM Response Criteria.
Progression-free Survival (PFS) Up to 2 years PFS is defined as the time from the date of the first dose of the study drug to the date of either the first documented disease progression (according to the Revised Response Criteria for Malignant Lymphoma and iwCLL Response Criteria and IWWM Response Criteria), or death due to any cause.
Trial Locations
- Locations (14)
Pratia Onkologia Katowice
🇵🇱Katowice, Poland
Chang-Gung Memorial Hospital, Kaohsiung
🇨🇳Kaohsiung County, Taiwan
Queen Mary University of London
🇬🇧Charterhouse Square, United Kingdom
Plymouth Hospitals NHS Trust
🇬🇧Plymouth, United Kingdom
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
China Medical University Hospital
🇨🇳Taichung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Arensia Exploratory Medicine
🇲🇩Chisinau, Moldova, Republic of
Pratia MCM Krakow
🇵🇱Krakow, Poland
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Centrum Medyczne Pratia Poznan
🇵🇱Skorzewo, Poland
Medical Center of Limited Liability Company Arensia Exploratory Medicine
🇺🇦Kiev, Ukraine