Brentuximab Vedotin for T-Cell Lymphoma
Trial Summary
What is the purpose of this trial?
This study will include patients with mature T-cell lymphoma (MTCL) that has been treated with at least one type of chemotherapy, but is not responding or coming back after the previous treatment. This clinical trial uses a drug called Brentuximab Vedotin. The Food and Drug Administration (FDA) has approved Brentuximab Vedotin for sale in the United States for certain diseases. Brentuximab is still being studied in clinical trials like this one to learn more about what its side effects are and whether or not it is effective in the disease or condition being studied. Brentuximab Vedotin is a type of drug called an antibody drug conjugate (ADC). ADCs usually have 2 parts; a part that targets cancer cells (the antibody) and a cell killing part (the chemotherapy). Antibodies are proteins that are part of your immune system. They can stick to and attack specific targets on cells. The antibody part of Brentuximab Vedotin sticks to a target called CD30. CD30 is an important molecule on some cancer cells (including non Hodgkin lymphoma) and some normal cells of the immune system. The cell killing part of Brentuximab Vedotin is a chemotherapy called monomethyl auristatin E (MMAE). It can kill cells that the antibody part of Brentuximab Vedotin sticks to. Brentuximab Vedotin has also been shown to kill cancer cells with levels of CD30 that cannot be seen by traditional methods. This study is being done to test if the study drug has an effect on Mature T cell Lymphoma with such low levels of a target called CD30 and how your disease respond to the study drug.
Research Team
Deepa Jagadeesh
Principal Investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Paolo F. Caimi
Principal Investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Eligibility Criteria
This trial is for adults with certain types of T-cell lymphoma that have low levels of CD30 and haven't responded to or relapsed after at least one chemotherapy treatment. Participants must be in relatively good health, not pregnant, willing to use contraception, and able to understand the study. They can't join if they've had certain other cancers recently, active infections including hepatitis B or C, heart problems, a history of HIV or PML disease.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Brentuximab Vedotin 1.8 mg/kg intravenously once every 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Brentuximab Vedotin
Brentuximab Vedotin is already approved in United States, European Union for the following indications:
- Hodgkin lymphoma
- Systemic anaplastic large cell lymphoma
- Primary cutaneous anaplastic large cell lymphoma
- CD30-expressing mycosis fungoides
- Peripheral T-cell lymphoma
- Hodgkin lymphoma
- Systemic anaplastic large cell lymphoma
- Cutaneous T-cell lymphoma
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Who Is Running the Clinical Trial?
Deepa Jagadeesh
Lead Sponsor