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
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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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