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Monoclonal Antibodies
JNJ-64264681 for Non-Hodgkin's Lymphoma and 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 must have Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a new drug to treat B cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. Researchers will determine the best dosage of the drug and then study how safe it is.
Who is the study for?
This trial is for adults with certain types of blood cancers, like Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia. They should be relatively healthy (ECOG grade 0 or 1), able to follow the study rules, and have normal heart rhythm readings. Women must test negative for pregnancy and agree not to donate eggs during the study.Check my eligibility
What is being tested?
The trial is testing JNJ-64264681's safety and optimal dose in two parts: first finding the best dose, then checking its safety at that dose in patients with B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).See study design
What are the potential side effects?
Potential side effects are not specified here but generally could include reactions related to immune system activation, infusion-related symptoms, fatigue, digestive issues or changes in blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 and Part 2: Number of Participants with Adverse Events (AEs)
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
Secondary outcome measures
Complete Response (CR) Rate
Duration of Response (DOR)
Overall Response Rate (ORR)
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: JNJ-64264681: Dose Escalation and ExpansionExperimental Treatment1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-64264681
2018
Completed Phase 1
~110
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Non-Hodgkin's Lymphoma (NHL) include monoclonal antibodies, kinase inhibitors, and immunotherapies. Monoclonal antibodies like rituximab target CD20 on B cells, leading to cell death.
Kinase inhibitors, such as ibrutinib, block Bruton's tyrosine kinase (BTK), disrupting B cell receptor signaling and inducing apoptosis. Immunotherapies, including CAR-T cell therapy, modify a patient's T cells to target and kill lymphoma cells.
These mechanisms are crucial for patients to understand as they explain how treatments work to control or eradicate the disease, aiding in better treatment outcomes and informed decision-making.
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Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
978 Previous Clinical Trials
6,385,009 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
747 Previous Clinical Trials
3,960,587 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.I haven't taken any experimental drugs or vaccines within the last 2 weeks or five half-lives before starting the study drug.My cancer has spread to my brain or spinal cord.I am allergic to JNJ-64264681 or its ingredients.I still have side effects from cancer treatment, except for hair loss or nerve issues.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: JNJ-64264681: Dose Escalation and Expansion
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.
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