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Monoclonal Antibodies

JNJ-67856633 for 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

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 4 years and 11 months

Awards & highlights

Study Summary

This trial is studying a drug to see what dose is safe and effective for people with relapsed or refractory B-cell non-Hodgkin lymphoma or chronic lymphocytic leukemia.

Who is the study for?

This trial is for adults with certain types of blood cancer, like Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia that has come back or didn't respond to treatment. They should have a heart rhythm within normal limits and be able to do most daily activities on their own. Women must test negative for pregnancy and both men and women need to use reliable birth control.Check my eligibility

What is being tested?

The study is testing the safety and best dose of a new drug called JNJ-67856633 in patients whose blood cancers have returned after treatment or haven’t responded at all. The goal is to find the highest dose patients can take without too many side effects.See study design

What are the potential side effects?

Specific side effects of JNJ-67856633 are not listed, but common ones for cancer treatments include nausea, fatigue, risk of infection, allergic reactions, and changes in blood counts. Side effects depend on how much medicine you get.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years and 11 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years and 11 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years and 11 months for reporting.

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) as a Measure of Safety and Tolerability

Part 1: Dose-Limiting Toxicity (DLT)

Secondary outcome measures

JNJ-67856633 Plasma Concentrations

Part 1 and Part 2: Complete Response Rate

Part 1 and Part 2: Duration of Response (DoR)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2 (Cohort Expansion): JNJ-67856633Experimental Treatment1 Intervention

Participants will receive JNJ-67856633 at the recommended Phase 2 dose (RP2D) determined in Part 1.

Group II: Part 1 (Dose Escalation): JNJ-67856633Experimental Treatment1 Intervention

Participants will receive JNJ-67856633 until disease progression, intolerable toxicity, withdrawal of consent, or the investigator or sponsor decision. Subsequent dose levels will be assigned by the sponsor using an adaptive dose escalation strategy based on all available safety, pharmacokinetic (PK), and biomarker data.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,082 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,679 Total Patients Enrolled

Media Library

JNJ-67856633 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03900598 — Phase 1

Non-Hodgkin's Lymphoma Research Study Groups: Part 1 (Dose Escalation): JNJ-67856633, Part 2 (Cohort Expansion): JNJ-67856633

Non-Hodgkin's Lymphoma Clinical Trial 2023: JNJ-67856633 Highlights & Side Effects. Trial Name: NCT03900598 — Phase 1

JNJ-67856633 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03900598 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the risk profile of JNJ-67856633 for those taking it?

"JNJ-67856633's safety is rated a 1 due to this trial being in its early stages, so there is only minimal data available on both efficacy and protection."

Answered by AI

Are there any vacancies open for participation in this research endeavor?

"According to the clinicaltrials.gov page, this investigation is not currently looking for participants at this time; it was first posted on April 3rd 2019 and last updated November 3rd 2022. However, there are 2879 other trials that do require enrollment today."

Answered by AI

What is the objective of this clinical experimentation?

"The primary metric of success in this 21-day medical trial is the number and severity of adverse events (AEs). Secondary objectives include a complete response rate according to iwCLL, non-Hodgkin lymphoma and Waldenstrom macroglobulinemia guidelines; evaluating the plasma concentrations of JNJ-67856633; and measuring time to response for those achieving partial or complete responses."

Answered by AI

Are there many medical facilities in the US actively engaging with this clinical research?

"At the moment, 6 different sites are enrolling individuals in this trial. These locations include New york, Omaha and Duarte as well as an additional 3 places. To reduce travel needs during participation it is suggested to select a centre closest to you."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of JNJ-67856633 in Participants With Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

2019. "A Study of JNJ-67856633 in Participants With Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03900598.

All > Hodgkins Lymphoma > Chronic Lymphocytic Leukemia