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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 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
~1720
Computed Tomography
2017
Completed Phase 2
~2720
Echocardiography
2013
Completed Phase 4
~11670
Positron Emission Tomography
2008
Completed Phase 2
~2210
Tazemetostat
2016
Completed Phase 2
~1050

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,601 Previous Clinical Trials
915,632 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,331 Total Patients Enrolled
Reem Karmali, MDPrincipal InvestigatorNorthwestern University
4 Previous Clinical Trials
61 Total Patients Enrolled
~21 spots leftby Apr 2026
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