Treatment Study for Newly Diagnosed High-Risk Diffuse Large B-Cell Lymphoma
Lymphoma is the general name for many related subtypes of cancer that arise from a type of white blood cell called a lymphocyte. It is the most common blood cancer and is divided into two major categories: Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). Lymphoma occurs when cells of the immune system called lymphocytes, a type of white blood cell, grow and multiply uncontrollably. Most lymphomas are found in the lymphatic system, which includes lymph nodes, the spleen and tonsils, for example.
Blinatumomab is a monoclonal antibody, a type of protein made in the laboratory that can bind to substances in the body. Monoclonal antibodies are being used to treat some types of cancer. They can be used alone or to carry drugs, toxins, or radioactive substances directly to cancer cells. Blinatumomab brings CD19-expressing tumor B-cells, cell-destroying T-lymphocytes, and helper T-lymphocytes together, which may result in cell death of the CD19-expressing B-cell lymphocytes.
This study consists of four time periods: a 2-week screening period to see if a patient can take part in the study; a run-in period, where eligible subjects receive standard of care chemotherapy; patients must meet additional study requirements in order to receive blinatumomab, the treatment with blinatumomab is a 12-16 week treatment period; the follow-up period consists of a safety follow-up visit 1 month after the last dose of blinatumomab, and then long-term follow-up of 1 year from the start of blinatumomab.
In order to participate you must meet the following criteria:
- Are 18 years of age or older at the time of informed consent.
- Have untreated high risk diffuse large B-cell lymphoma, have double-hit lymphoma, or lymphoma with double protein expression.
- Meet the criteria to receive 6 cycles of standard of care R-chemotherapy (rituximab + CHOP or rituximab + dose adjusted EPOCH/R-CHOEP).
You will be excluded from the study if any of the following criteria apply to you:
- Have central nervous system (CNS) pathology requiring treatment, such as epilepsy, seizure, aphasia, stroke, severe brain injury, dementia, or Parkinson’s disease.
- Have lymphoma that shows signs of CNS involvement.
- Have received anti-CD19 therapies before for your disease.
This is a partial list of inclusion and exclusion criteria.