Clinical trial NCT04210219: A Study of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Lymphoma, Non-Hodgkin
Leukemia, Lymphocytic, Chronic, B-Cell
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-12-24
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
timeFrame: Up to 21 days
measure: Part 1 and Part 2: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Plasma Concentration of JNJ-64264681
timeFrame: Up to 2 years
measure: Percentage Occupancy of the Target
timeFrame: Up to 2 years
measure: Overall Response Rate (ORR)
timeFrame: Up to 2 years
measure: Time to Response (TTR)
timeFrame: Up to 2 years
measure: Duration of Response (DOR)
timeFrame: Up to 2 years
measure: Complete Response (CR) Rate
timeFrame: Up to 2 years
measure: Progression-free Survival (PFS)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Tbilisi
country: Georgia
facility: Arensia Exploratory Medicine
city: Chisinau
country: Moldova, Republic of
facility: Arensia Exploratory Medicine
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Katowice
country: Poland
facility: Pratia Onkologia Katowice
city: Krakow
country: Poland
facility: Pratia MCM Krakow
city: Skorzewo
country: Poland
facility: Centrum Medyczne Pratia Poznan
city: Kaohsiung County
country: Taiwan
facility: Chang-Gung Memorial Hospital, Kaohsiung
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Kyiv
country: Ukraine
facility: Medical Center of Limited Liability Company Arensia Exploratory Medicine
city: Charterhouse Square
country: United Kingdom
facility: Queen Mary University of London
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: