Brentuximab Vedotin + Chemotherapy for Hodgkin's Lymphoma
Trial Summary
What is the purpose of this trial?
This pilot phase I/II trial studies the side effects and the best dose of brentuximab vedotin when given together with combination chemotherapy and to see how well they work in treating patients with stage II-IV human immunodeficiency virus (HIV)-associated Hodgkin lymphoma. Brentuximab vedotin is a monoclonal antibody, called brentuximab, linked to a chemotherapy drug called vedotin. Brentuximab attaches to CD30-positive cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving brentuximab vedotin together with combination chemotherapy may kill more cancer cells.
Research Team
Paul G Rubinstein
Principal Investigator
AIDS Malignancy Consortium
Eligibility Criteria
This trial is for HIV-positive patients with stage II-IV Hodgkin lymphoma who haven't had certain treatments. They must be on antiretroviral therapy, have adequate organ function, and agree to use contraception. Excluded are those with severe neuropathy, central nervous system disease, cirrhosis, recent heart issues or other serious medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive doxorubicin hydrochloride, vinblastine sulfate, dacarbazine, and brentuximab vedotin intravenously on days 1 and 15, repeating every 28 days for up to 6 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment completion every 3 months for 2 years and then every 6 months for 3 years
Treatment Details
Interventions
- Brentuximab Vedotin
- Dacarbazine
- Doxorubicin Hydrochloride
- Vinblastine
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?
National Cancer Institute (NCI)
Lead Sponsor
The Lymphoma Academic Research Organisation
Collaborator