Clinical Trial NU 12H09
- A Phase I-II Trial of Brentuximab Vedotin Plus Rituximab as Frontline Therapy for Patients with CD30+ and/or EBV+ Lymphomas
- Principal Investigator
- Jason Kaplan
- Status: SUSPENDED
- Study Type: Therapeutic, Treatment
- Protocol No:.NU 12H09
- The purpose of this study is to evaluate how safe and effective the combination of two different drugs (brentuximab vedotin and rituximab) is in patients with certain types of lymphoma.
- This study is for patients who have a type of lymphoma that expresses a tumor marker called CD30 and/or a type that is associated with the Epstein-Barr virus (EBV-related lymphoma) and who have not yet received any treatment for their cancer, except for dose-reduction or discontinuation (stoppage) of medications used to prevent rejection of transplanted organs (for those patients who have undergone transplantation). Standard treatment for these types of lymphomas include various combinations of chemotherapy. However, , these combination treatments seem to cause excessive toxicity (side effects) in patients with this type of lymphoma, and even when the treatment is well-tolerated, the lymphoma will return for many patients. Therefore, additional treatment options are needed. This study is investigating the combination of brentuximab vedotin and rituximab as a first treatment for lymphoma patients. Brentuximab vedotin is an investigational drug. The Food and Drug Administration (FDA) has approved brentuximab vedotin for use in some types of lymphoma, where the cancer has either returned or continued to get worse after receiving other types of treatment; however, it is not yet approved for patients with lymphoma who have not yet received other treatments, which is why its use in this study is considered investigational. Rituximab has been approved by the FDA for some, but not all, types of lymphoma, where the cancer has not been treated and in cases where the disease has either returned or continued to progress. Rituximab will be considered an approved and standard treatment during this study.
Some of the eligibility criteria include:
- Participants must have lymphoma that is CD30+ and/or EBV+, and that also is positive for CD20 expression. This is determined by the pathologist who diagnoses the cancer based upon review of a biopsy specimen.
- Participants may not have prior chemotherapy, radiotherapy or surgery. Exceptions include instances when a doctor tells a patient to stop or reduce immunosuppressant (anti-rejection) medications in an effort to restore the body’s ability to fight the lymphoma.
- Participants must be 18 or older.
- Description of Treatment
- Participants will receive brentuximab vedotin treatments in periods called cycles; each cycle will be 28 days long at the beginning of the treatment, then cycles will be 21 days long, later in the course of treatment. Brentuximab vedotin is given as an intravenous (IV) infusion through a vein in the arm, or through a port or PICC line that has already been placed in the participant's body. During Cycle 1, participants will receive brentuximab vedotin once a week; after Cycle 1, they will receive brentuximab vedotin once per cycle (every 3 weeks). Rituximab is also given as an IV infusion through a vein in the arm, or through a port or PICC line. Participants will receive weekly doses of rituximab for the first 4 weeks that they are on the study. After that, they will receive rituximab treatments every 6 weeks.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 09-Dec-16 01:43 AM
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