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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04210219
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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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
Lymphoma, Non-Hodgkin Leukemia, Lymphocytic, Chronic, B-Cell Drug: JNJ-64264681 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2, 2020
Estimated Primary Completion Date : May 5, 2022
Estimated Study Completion Date : September 5, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Part 1: Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Up to 2 years ]
    Plasma concentration of JNJ-64264681 will be evaluated.

  2. Percentage Occupancy of the Target [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04210219


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Georgia
Arensia Exploratory Medicine Recruiting
Tbilisi, Georgia, 0112
Moldova, Republic of
Arensia Exploratory Medicine Recruiting
Chisinau, Moldova, Republic of, MD-2025
Poland
Uniwersyteckie Centrum Kliniczne Recruiting
Gdansk, Poland, 80-214
Pratia Onkologia Katowice Recruiting
Katowice, Poland, 40-519
Pratia MCM Krakow Recruiting
Krakow, Poland, 30-510
Centrum Medyczne Pratia Poznan Recruiting
Skorzewo, Poland, 60-185
Taiwan
Chang-Gung Memorial Hospital, Kaohsiung Recruiting
Kaohsiung County, Taiwan, 83301
China Medical University Hospital Recruiting
Taichung, Taiwan, 40402
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 70403
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10048
Ukraine
ARENSIA Exploratory Medicine Unit Suspended
Kiev, Ukraine, 8112
United Kingdom
Queen Mary University of London Recruiting
Charterhouse Square, United Kingdom, EC1M 6BQ
St James University Hospital Withdrawn
Leeds, United Kingdom, LS9 7TF
Plymouth Hospitals NHS Trust Recruiting
Plymouth, United Kingdom, PL6 8DH
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04210219    
Other Study ID Numbers: CR108706
2019-003194-25 ( EudraCT Number )
64264681LYM1001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell