Brentuximab Vedotin for T-Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a drug called Brentuximab Vedotin for individuals with mature T-cell lymphoma that hasn't responded well to previous chemotherapy. The drug targets and kills cancer cells with low levels of a molecule called CD30, often present on these cancer cells. Patients who have tried at least one chemotherapy treatment and whose lymphoma remains unresponsive might be suitable candidates. The main goal is to evaluate the drug's effectiveness and learn more about its side effects. As a Phase 2 trial, this research focuses on assessing the treatment's efficacy in an initial, smaller group of participants.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy or investigational agents within 2 weeks before starting the study treatment.
Is there any evidence suggesting that Brentuximab Vedotin is likely to be safe for humans?
Research has shown that Brentuximab Vedotin is generally well-tolerated in people with certain types of cancer. Studies have found that it has a manageable safety profile, with most side effects not being severe. Serious side effects, such as pneumonia and fever, occur in about 4% of patients. Some individuals also experienced vomiting, nausea, liver issues, and nerve problems, though these were less common.
The FDA has already approved Brentuximab Vedotin for other cancers, indicating prior safety studies. However, since this trial tests it for a new condition, ongoing monitoring of its effects remains important. Participants should discuss any concerns with their doctors and report any unusual symptoms during the trial.12345Why do researchers think this study treatment might be promising?
Brentuximab vedotin is unique because it specifically targets a protein called CD30, which is often found on the surface of T-cell lymphoma cells. Unlike traditional chemotherapy that attacks rapidly dividing cells indiscriminately, brentuximab vedotin delivers a potent anti-cancer drug directly to the cancer cells, minimizing damage to healthy cells. This targeted approach not only aims to improve effectiveness but also potentially reduces side effects compared to conventional treatments. Researchers are excited about this treatment because it offers a more precise attack on the cancer cells, which could lead to better outcomes for patients with T-cell lymphoma.
What evidence suggests that Brentuximab Vedotin might be an effective treatment for T-cell lymphoma?
Research has shown that Brentuximab Vedotin, the treatment under study in this trial, can benefit individuals with certain types of lymphoma. In one study involving 58 patients, 86% responded to the treatment, and 57% achieved complete remission, meaning their cancer was undetectable after treatment. Brentuximab Vedotin targets a protein called CD30 found on some cancer cells, including those in T-cell lymphoma. The treatment uses an antibody to locate and attach to cancer cells, combined with a chemotherapy agent that kills them. This makes Brentuximab Vedotin a promising option, particularly for patients whose cancer has low levels of CD30.6789
Who Is on the 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
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Deepa Jagadeesh
Lead Sponsor