Study on Pembrolizumab and Tazemetostat for Patients with Aggressive B-Cell Non-Hodgkin's Lymphoma After Stem Cell or CAR T-Cell Therapy

Sponsor: Northwestern University

Sponsor score: 0

ClinicalTrials ID:NCT06242834

Provider View

This clinical trial is exploring whether the combination of pembrolizumab and tazemetostat can help treat patients with aggressive B-cell Non-Hodgkin's Lymphoma who have already undergone stem cell or CAR T-cell therapy. The study aims to see if these drugs can improve patient outcomes by overcoming immune tolerance.

Patient Parameters

Program Overview

This phase II study is testing how well two drugs, pembrolizumab and tazemetostat, work together to treat patients with aggressive B-cell Non-Hodgkin's Lymphoma who have already received either autologous stem cell transplantation (ASCT) or CAR T-cell therapy. Pembrolizumab is a type of protein that helps the immune system target cancer cells, while tazemetostat may stop cancer cells from growing by blocking certain enzymes. The study aims to find out if this combination can better treat patients who have already undergone these therapies.

Description

The main goal of this study is to see if the combination of pembrolizumab and tazemetostat can help patients with aggressive B-cell Non-Hodgkin's Lymphoma live longer without the cancer getting worse after they have received ASCT or CAR T-cell therapy. Researchers will also look at how long patients live overall, how safe the treatment is, and how well it works in shrinking tumors.

Participants will start treatment 14 days after their standard ASCT or CAR T-cell therapy. They will receive pembrolizumab through an IV on the first day of each cycle. Starting from the second cycle, they will also take tazemetostat pills twice a day for 21 days. Each cycle lasts 21 days, and the treatment will continue for up to 12 months unless the cancer progresses or side effects become too severe.

Throughout the study, participants will have various tests, including heart scans, CT scans, PET scans, and blood tests, to monitor their health and the treatment's effects. After completing the treatment, patients will be followed up within 90 days and periodically for up to 18 months.

Eligibility Criteria

Inclusion Criteria

  • Must have aggressive B-cell Non-Hodgkin's Lymphoma and be undergoing or have undergone ASCT or CAR T-cell therapy.
  • Must be 18 years or older.
  • Must have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
  • Must have a life expectancy of more than 12 weeks.
  • Must have certain blood counts and organ function levels within specified limits.
  • Women of childbearing potential must agree to use effective contraception during the study and for six months after.
  • Men must agree to use condoms during the study and for six months after.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Currently participating in another clinical trial or have used an investigational drug within 28 days before starting this study.
  • Have received certain prior therapies, such as anti-PD-1 or EZH2 inhibitors.
  • Have had major surgery within four weeks before starting tazemetostat.
  • Have a history of certain infections, like HIV or chronic hepatitis B, unless under control.
  • Have a history of certain blood cancers or allergic reactions to the study drugs.
  • Have active autoimmune diseases requiring treatment in the past two years.
  • Have received a live vaccine within 30 days before starting the study.
  • Have uncontrolled illnesses, such as severe heart disease or active infections.
  • Women who are pregnant or breastfeeding.

Locations

FACILITYZIPCITYSTATE
Northwestern University60611ChicagoIllinois

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