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Monoclonal Antibodies
JNJ-64264681 + JNJ-67856633 for Chronic Lymphocytic Leukemia
Phase 1
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with B cell non-Hodgkin lymphoma (NHL) must have tumor tissue available at baseline as described in the protocol. This is not required for participants with chronic lymphocytic leukemia (CLL)
Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years and 9 months
Awards & highlights
Study Summary
This trial is testing two drugs to see what the best dose is to treat B cell NHL and CLL, and also to see how safe they are in different populations.
Who is the study for?
This trial is for adults with certain types of blood cancers, like Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia. They should be relatively healthy (ECOG grade 0 or 1), have a specific heart rhythm measurement within normal limits, and women must use effective contraception. People who've had previous treatments with the study drugs or certain other cancer therapies can't join.Check my eligibility
What is being tested?
The trial is testing two drugs, JNJ-64264681 and JNJ-67856633, to find safe doses when used together in patients with B cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. It has two parts: dose finding (Part A) and checking safety across different patient groups (Part B).See study design
What are the potential side effects?
Potential side effects aren't specified here but typically could include reactions at the infusion site, fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems, liver function changes, allergic reactions or other organ-specific issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have B cell non-Hodgkin lymphoma and my tumor tissue is available for testing.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years and 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years and 9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A and Part B: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Part A: Number of Participants with Dose-limiting Toxicity (DLT)
Secondary outcome measures
Bruton's Tyrosine Kinase (BTK) Occupancy in Peripheral Blood Mononuclear Cell (PBMCs)
Duration of Response
Overall Response Rate (ORR)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Part B: Cohort Expansion: JNJ-64264681 and JNJ-67856633Experimental Treatment2 Interventions
Participants will receive JNJ-64264681 and JNJ-67856633 at the recommended Phase 2 dose (RP2D) determined in Part 1.
Group II: Part A: Dose escalation: JNJ-64264681 and JNJ-67856633Experimental Treatment2 Interventions
Participants will receive JNJ-64264681 and JNJ-67856633 will be administered together until disease progression, intolerable toxicity, withdrawal of consent, or the investigator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-64264681
2018
Completed Phase 1
~110
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,233 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialsStudy DirectorJanssen Research & Development, LLC
11 Previous Clinical Trials
201,922 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to my brain or spinal cord.I have previously been treated with JNJ 64264681 or JNJ-67856633, or stopped a BTK/MALT inhibitor without bad side effects.Side effects from my past cancer treatments have mostly gone away or are mild.I have B cell non-Hodgkin lymphoma and my tumor tissue is available for testing.I am fully active or restricted in physically strenuous activity but can do light work.I am allergic to JNJ-64264681, JNJ 67856633, or their ingredients.
Research Study Groups:
This trial has the following groups:- Group 1: Part A: Dose escalation: JNJ-64264681 and JNJ-67856633
- Group 2: Part B: Cohort Expansion: JNJ-64264681 and JNJ-67856633
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what aim is this research endeavor aspiring?
"This clinical trial, which is slated to run up to two years and three months, seeks to measure the number of participants who suffer from dose-limiting toxicity. Other metrics that will be monitored include plasma concentrations of JNJ-64264681 and JNJ-67856633, duration of response, as well as Bruton's Tyrosine Kinase (BTK) occupancy in peripheral blood mononuclear cells (PBMCs)."
Answered by AI
Are any new participants being admitted for this experimental trial at the moment?
"According to the entry hosted on clinicaltrials.gov, this medical study is not actively recruiting candidates at present. This project was initially posted in February 25th 2021 and last updated December 1st 2022; however, there are 2881 other trials that are seeking patients right now."
Answered by AI
To what extent has JNJ-64264681 been proven to be safe for human consumption?
"Given that this is a first-phase trial, with limited evidence for safety and efficacy, our internal team at Power assigned JNJ-64264681 a score of 1 on the risk assessment scale."
Answered by AI
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