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A Study of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

Primary Purpose

Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
JNJ-64264681
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Icahn School of Medicine at Mount Sinai
  • Arensia Exploratory Medicine
  • Arensia Exploratory Medicine
  • Uniwersyteckie Centrum Kliniczne
  • Pratia Onkologia Katowice
  • Pratia MCM Krakow
  • Centrum Medyczne Pratia Poznan
  • Chang-Gung Memorial Hospital, Kaohsiung
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Medical Center of Limited Liability Company Arensia Exploratory Medicine
  • Queen Mary University of London
  • Plymouth Hospitals NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

JNJ-64264681: Dose Escalation and Expansion

Arm Description

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).

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Plasma Concentration of JNJ-64264681
Plasma concentration of JNJ-64264681 will be evaluated.
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).
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 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.
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.
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.
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.

Full Information

First Posted
December 23, 2019
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04210219
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2, 2020 (Actual)
Primary Completion Date
April 4, 2025 (Anticipated)
Study Completion Date
April 6, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JNJ-64264681: Dose Escalation and Expansion
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
JNJ-64264681
Intervention Description
JNJ-64264681 capsule will be administered orally.
Primary Outcome Measure Information:
Title
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
Description
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
Title
Part 1 and Part 2: Number of Participants with Adverse Events (AEs)
Description
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
Secondary Outcome Measure Information:
Title
Plasma Concentration of JNJ-64264681
Description
Plasma concentration of JNJ-64264681 will be evaluated.
Time Frame
Up to 2 years
Title
Percentage Occupancy of the Target
Description
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
Title
Overall Response Rate (ORR)
Description
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
Title
Time to Response (TTR)
Description
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.
Time Frame
Up to 2 years
Title
Duration of Response (DOR)
Description
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
Title
Complete Response (CR) Rate
Description
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
Title
Progression-free Survival (PFS)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Arensia Exploratory Medicine
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Arensia Exploratory Medicine
City
Chisinau
ZIP/Postal Code
MD-2025
Country
Moldova, Republic of
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Pratia Onkologia Katowice
City
Katowice
ZIP/Postal Code
40-519
Country
Poland
Facility Name
Pratia MCM Krakow
City
Krakow
ZIP/Postal Code
30-727
Country
Poland
Facility Name
Centrum Medyczne Pratia Poznan
City
Skorzewo
ZIP/Postal Code
60-185
Country
Poland
Facility Name
Chang-Gung Memorial Hospital, Kaohsiung
City
Kaohsiung County
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40402
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Medical Center of Limited Liability Company Arensia Exploratory Medicine
City
Kiev
ZIP/Postal Code
1135
Country
Ukraine
Facility Name
Queen Mary University of London
City
Charterhouse Square
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Facility Name
Plymouth Hospitals NHS Trust
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

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