Study on Pemigatinib for Patients with Relapsed or Hard-to-Treat B-cell Non-Hodgkin Lymphomas

Sponsor: University of Utah

Sponsor score: 0

ClinicalTrials ID:NCT06300528

This clinical trial is testing the effectiveness of the drug pemigatinib in treating patients with B-cell non-Hodgkin lymphomas that have returned or are not responding to treatment.

Patient Parameters

Program Overview

The aim of this study is to find out if the drug pemigatinib can help treat patients with B-cell non-Hodgkin lymphomas that have either come back after treatment or are not responding to current treatments. The study will involve patients who meet specific health criteria and have tried other treatments without success.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 2 or less, meaning you are able to carry out all self-care but unable to carry out any work activities.
  • Have a confirmed diagnosis of certain types of B-cell non-Hodgkin lymphomas, including Mantle Cell Lymphoma (MCL) and Marginal Zone Lymphoma (MZL).
    • For patients with gastric MALT lymphoma who are H. Pylori positive, you must have tried and not succeeded with H. Pylori eradication and either cannot have, have refused, or have not succeeded with gastric radiation therapy.
  • Have received at least two previous treatments and do not have any FDA-approved therapies available or have refused them.
  • Previous treatments like autologous stem cell transplant or CAR-T cell therapy are allowed if completed at least 3 months or 1 month ago, respectively.
  • Must need systemic treatment.
  • Have at least one tumor that can be measured by a CT scan.
  • Have a life expectancy of more than 3 months.
  • Have adequate organ function, including specific blood counts and liver and kidney function.
  • Women must have a negative pregnancy test or be post-menopausal.
  • Must agree to use effective birth control if of childbearing potential.
  • Must be able to swallow tablets.
  • Must have recovered from any side effects of previous treatments to a certain level.
  • Must be able to understand and agree to participate in the study.

Exclusion Criteria

  • Have previously received an FGFR inhibitor.
  • Have a condition that affects the absorption of the study drug.
  • Are currently receiving other cancer treatments not allowed by the study.
  • Have had certain cancer treatments within a specified time before starting the study.
  • Have had major surgery recently and not fully recovered.
  • Have another active cancer that could affect participation.
  • Have cancer that has spread to the brain.
  • Have uncontrolled or significant health issues, including certain heart conditions.
  • Have an active infection like HIV or hepatitis B or C.
  • Have a history of abnormal calcium deposits in the body.
  • Have significant eye problems.
  • Are taking certain medications that affect the study drug.
  • Have a history of severe allergic reactions to the study drug.
  • Have any condition that would make it difficult to follow the study procedures.

Locations

FACILITYZIPCITYSTATE
Huntsman Cancer Institute at University of Utah84112Salt Lake CityUtah

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