Clinical Trial TitleA phase 2 open-label study of brentuximab vedotin in front-line therapy of Hodgkin lymphoma and CD30-expressing peripheral T-cell lymphoma in older patients or patients with significant comorbidities ineligible for standard chemotherapy.
National Clinical Trial Number:NCT01716806
Clinical Trial Protocol Description:
Hodgkin lymphoma (HL) is a disease in which cancer cells form in the lymph system, part of the body’s immune system. HL has been divided into two main classifications, classical Hodgkin lymphoma (which accounts for about 95% of all cases of HL) and lymphocyte predominant HL.
Peripheral T-cell lymphoma (PTCL) consists of a group of rare and usually aggressive (fast-growing) Non Hodgkin Lymphomas (NHLs) that develop from mature T-cells. Most T-cell lymphomas are PTCLs, which collectively account for about 10 to 15 percent of all NHL cases in the United States.
Brentuximab vedotin is a CD30-directed antibody drug conjugate (ADC). It consists of a targeted therapy monoclonal antibody and a chemotherapy drug. The brentuximab portion of the drug is a monoclonal antibody which targets the CD30 antigen on the surface of the cancer cells. HL cells usually have the CD30 molecule on their surface. The antibody acts like a homing signal, bringing the chemotherapy drug to the lymphoma cells, where it enters the cells and makes them die when they try to divide into new cells.
This study has been going on for a while to study brentuximab vedotin either alone or with other drugs to treat patients with HL. In this part of the study, we want to find out if brentuximab vedotin works as the first treatment for either HL or PTCL.
If you join this study, you will receive brentuximab vedotin in 21 day cycles. If your cancer is stable or gets better, you may get up to 16 cycles of brentuximab vedotin. After you have stopped getting brentuximab vedotin, we will ask you to have follow-up visits or follow-up phone calls about every 3 months until the study is closed.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Have a diagnosis of classical HL, which excludes nodular lymphocyte-predominant HL, or CD30-expressing PTCL and have not received treatment for this disease before.
- Are not able to have or tolerate initial conventional combination chemotherapy for HL or CD30-expressing PTCL due to the presence of other disease-related factors.
- Hhave adequate organ function.
You will be excluded from the study if any of the following criteria apply to you:
- Have symptomatic neurologic disease compromising your instrumental activities of daily living.
- Have a history of progressive multifocal leukoencephalopathy (PML).
- Have any significant viral, bacterial, or fungal infection.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.