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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04210219
Collaborator
(none)
108
16
1
53.4
6.8
0.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 2, 2020
Anticipated Primary Completion Date :
Dec 12, 2024
Anticipated Study Completion Date :
Dec 12, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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).

Drug: JNJ-64264681
JNJ-64264681 capsule will be administered orally.

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. 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

  1. Plasma Concentration of JNJ-64264681 [Up to 2 years]

    Plasma concentration of JNJ-64264681 will be evaluated.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Icahn School of Medicine at Mount Sinai New York New York United States 10029
2 Arensia Exploratory Medicine Tbilisi Georgia 0112
3 Arensia Exploratory Medicine Chisinau Moldova, Republic of MD-2025
4 Uniwersyteckie Centrum Kliniczne Gdansk Poland 80-214
5 Pratia Onkologia Katowice Katowice Poland 40-519
6 Pratia MCM Krakow Krakow Poland 30-510
7 Centrum Medyczne Pratia Poznan Skorzewo Poland 60-185
8 Chang-Gung Memorial Hospital, Kaohsiung Kaohsiung County Taiwan 83301
9 China Medical University Hospital Taichung Taiwan 40402
10 Taichung Veterans General Hospital Taichung Taiwan 40705
11 National Cheng Kung University Hospital Tainan Taiwan 70403
12 National Taiwan University Hospital Taipei Taiwan 10048
13 ARENSIA Exploratory Medicine Unit Kiev Ukraine 8112
14 Queen Mary University of London Charterhouse Square United Kingdom EC1M 6BQ
15 St James University Hospital Leeds United Kingdom LS9 7TF
16 Plymouth Hospitals NHS Trust Plymouth United Kingdom PL6 8DH

Sponsors and Collaborators

  • Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT04210219
Other Study ID Numbers:
  • CR108706
  • 2019-003194-25
  • 64264681LYM1001
First Posted:
Dec 24, 2019
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2022