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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
85
JNJ-64264681 capsule will be administered orally.
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Arensia Exploratory Medicine
Tbilisi, Georgia
Arensia Exploratory Medicine
Chisinau, Moldova
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
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).
Time frame: Up to 21 days
Part 1 and Part 2: Number of Participants with Adverse Events (AEs)
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.
Time frame: Up to 2 years
Plasma Concentration of JNJ-64264681
Plasma concentration of JNJ-64264681 will be evaluated.
Time frame: Up to 2 years
Percentage Occupancy of the Target
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).
Time frame: Up to 2 years
Overall Response Rate (ORR)
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 frame: Up to 2 years
Time to Response (TTR)
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.
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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
...and 5 more locations
Time frame: Up to 2 years
Duration of Response (DOR)
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.
Time frame: Up to 2 years
Complete Response (CR) Rate
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.
Time frame: Up to 2 years
Progression-free Survival (PFS)
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.
Time frame: Up to 2 years