Open-label Study of Loncastuximab Tesirine for Treating Relapsed or Difficult-to-Treat Marginal Zone Lymphoma

Sponsor: University of Miami

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05296070

This clinical trial is exploring the effects of the drug loncastuximab tesirine on patients with marginal zone lymphoma that has returned or is not responding to treatment. The study aims to understand both the benefits and side effects of this medication.

Patient Parameters

Program Overview

The purpose of this study is to determine if the drug loncastuximab tesirine can help patients with marginal zone lymphoma (MZL) that has come back or is not responding to other treatments. Researchers want to see how this drug affects the cancer and the patient's overall health.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Diagnosed with marginal zone lymphoma (MZL), including types that affect different areas like extranodal, nodal, and splenic.
  • Previously treated with at least one systemic therapy, including an anti-CD20 antibody, and the cancer has either progressed or not fully responded.
  • Have measurable cancer by scans or other criteria, or specific conditions for those with splenic, skin, gastric, or conjunctival MZL.
  • Willing to provide a tissue sample for testing.
  • Meet certain health criteria, such as having multiple large lymph nodes, symptoms like fever or weight loss, or other specific conditions related to the cancer.
  • Life expectancy of more than 3 months.
  • Good overall health with a performance status score of 0 to 2.
  • Adequate blood, liver, and kidney function based on specific tests.
  • Agree to use effective birth control during and after the study to prevent pregnancy.

Exclusion Criteria

  • Evidence of transformation to a more aggressive type of lymphoma.
  • History of lymphoma affecting the brain or spinal fluid.
  • Currently receiving other cancer treatments.
  • Recent stem cell transplant.
  • Active graft versus host disease.
  • Recent use of certain cancer medications or treatments.
  • Not fully recovered from major surgery or previous treatment side effects.
  • Previous treatment with anti-CD19 therapies.
  • Other cancers within the last 3 years, except for certain non-threatening types.
  • Serious uncontrolled medical conditions.
  • Active infections requiring treatment or recent live vaccine.
  • HIV infection or certain liver infections unless controlled.
  • Heart failure or uncontrolled heart rhythm issues.
  • Currently pregnant or breastfeeding.
  • Any condition that might interfere with participating in the study or understanding the results.

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