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Monoclonal Antibodies

Treatment (pembrolizumab, tazemetostat) for Non-Hodgkin's Lymphoma

Phase 2

Waitlist Available

Led By Reem Karmali, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a histo-pathologically confirmed aggressive B-cell NHL intended for or currently undergoing standard of care ASCT or CAR T-cell therapy

Patients should have met the FDA approved indications for the respective CAR T cell construct being used

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from asct or car t-cell infusion until death from any cause, up to 3 years

Awards & highlights

Study Summary

This trial aims to see how well pembrolizumab and tazemetostat work together to treat patients with aggressive non-Hodgkin's lymphoma who have previously undergone autologous

Who is the study for?

This trial is for patients with aggressive B-cell Non-Hodgkin's Lymphoma who have already undergone autologous stem cell transplantation (ASCT) or chimeric antigen receptor (CAR) T-cell therapy. Specific eligibility criteria are not provided, but typically include factors like age, health status, and previous treatments.Check my eligibility

What is being tested?

The trial is testing the combination of pembrolizumab (a monoclonal antibody that helps the immune system detect and fight cancer cells) and tazemetostat (a drug that may stop cancer growth by blocking certain enzymes), to see if they can improve outcomes in patients post-ASCT or CAR-T therapy.See study design

What are the potential side effects?

Potential side effects from pembrolizumab could include fatigue, skin reactions, diarrhea, liver inflammation, and infusion-related reactions. Tazemetostat might cause tiredness, nausea, loss of appetite or weight loss. Side effects vary among individuals.

Eligibility Criteria

Inclusion Criteria

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

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I have aggressive B-cell NHL and am getting a stem cell transplant or CAR T-cell therapy.

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I meet the FDA requirements for my specific CAR T cell therapy.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My PET/CT scan shows active cancer before starting CAR T-cell therapy.

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I am in complete remission and ready for stem cell transplant.

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My kidneys are functioning well enough, with a creatinine clearance of 30 mL/min or more.

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I have had hepatitis C but my viral load is now undetectable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from asct or car t-cell infusion until death from any cause, up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from asct or car t-cell infusion until death from any cause, up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from asct or car t-cell infusion until death from any cause, up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Event free survival

Secondary outcome measures

Complete response rate

Incidence of adverse events

Objective response rate (ORR)

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab, tazemetostat)Experimental Treatment6 Interventions

Starting on day 14 after standard of care ASCT or CAR-T cell treatment patients receive pembrolizumab IV on day 1 of each cycle. Starting cycle 2, patients receive tazemetostat PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography during screening, CT scan, PET scan, and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Biospecimen Collection

2004

Completed Phase 2

~1700

Computed Tomography

2017

Completed Phase 2

~2720

Echocardiography

2013

Completed Phase 4

~11670

Positron Emission Tomography

2008

Completed Phase 2

~2240

Tazemetostat

2016

Completed Phase 2

~1050

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,591 Previous Clinical Trials

917,620 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,680 Previous Clinical Trials

40,928,487 Total Patients Enrolled

Reem Karmali, MDPrincipal InvestigatorNorthwestern University

4 Previous Clinical Trials

61 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available slots for patients to participate in this clinical trial?

"According to clinicaltrials.gov, the recruitment for this specific clinical trial is presently closed. The trial was first listed on 4/24/2024 and last updated on 1/29/2024. Despite this particular study not seeking participants currently, there are numerous other trials actively enrolling individuals, with a total of 1714 options available."

Answered by AI

Has the therapy combination of pembrolizumab and tazemetostat received approval from the FDA for use?

"Given that this is a Phase 2 study, the safety rating for Treatment (pembrolizumab, tazemetostat) by our team at Power stands at 2. This indicates some existing data supporting its safety profile but none indicating efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab and Tazemetostat to Overcome Immune Tolerance Following ASCT or CAR T-cell Therapy in Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma

2024. "Pembrolizumab and Tazemetostat to Overcome Immune Tolerance Following ASCT or CAR T-cell Therapy in Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06242834.

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