Study Comparing Loncastuximab Tesirine and Rituximab with Standard Immunochemotherapy for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Sponsor: ADC Therapeutics S.A.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04384484

This clinical trial is testing whether a new combination of drugs, loncastuximab tesirine and rituximab, is more effective than the usual immunochemotherapy for patients with Diffuse Large B-Cell Lymphoma that has returned or not responded to treatment.

Patient Parameters

Program Overview

The aim of this study is to see if the combination of loncastuximab tesirine and rituximab can better treat Diffuse Large B-Cell Lymphoma (DLBCL) that has come back or not responded to previous treatments, compared to the standard immunochemotherapy.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL) or high-grade B-cell lymphoma with specific genetic changes.
  • The cancer must have returned after treatment or not responded to at least one previous treatment.
  • Not suitable for stem cell transplantation due to health status, age, or other medical conditions.
  • Have measurable cancer as determined by specific imaging tests.
  • Provide a tumor sample for testing.
  • Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Have adequate organ function based on specific blood test results.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
  • Men must agree to use a condom or practice abstinence during and after the study if their partner is of childbearing potential.

Exclusion Criteria

  • Have previously been treated with loncastuximab tesirine or R-GemOx.
  • Have allergies to certain antibodies or components of the study drugs.
  • Have Burkitt lymphoma.
  • Have another active cancer, except for certain non-threatening types.
  • Have had a stem cell transplant recently.
  • Have active graft-versus-host disease.
  • Have an active autoimmune disease.
  • Have HIV with certain conditions, such as low CD4 counts or high viral load.
  • Have active hepatitis B or C infections.
  • Have a history of severe skin reactions.
  • Have cancer that has spread to the brain or spinal cord.
  • Have significant fluid buildup in the body.
  • Are pregnant or breastfeeding.
  • Have uncontrolled high blood pressure or serious heart conditions.
  • Have had major surgery or certain treatments recently.
  • Have used experimental medications or received live vaccines recently.
  • Have not recovered from previous treatment side effects.
  • Have a heart condition known as long QT syndrome.
  • Have any other serious medical condition that could affect participation in the study.
  • Have allergies to certain chemotherapy drugs.

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