Relapsed or Refractory Non-Hodgkin’s B-Cell Lymphoma Treatment Study
Lymphoma is the most common blood cancer. Lymphoma occurs when cells of the immune system called lymphocytes, a type of white blood cell, grow and multiply uncontrollably. Recurrent disease is the term used to describe disease that returns after an initial remission. Refractory disease is the term used to describe disease that does not fully respond to initial treatment.
MT-3724 is an immunotoxin which is an antibody linked to a toxic substance. Some immunotoxins can bind to cancer cells and kill them. MT-3724 targets the CD20 cell surface antigen present in a variety of lymphomas and leukemias.
During this study, MT-3724 will be given to participating subjects with a combination of two other chemotherapy drugs called gemcitabine and oxaliplatin. Gemcitabine and oxaliplatin have been approved by the FDA to treat some cancers. This combination of drugs is often referred to as GEMOX.
This study will be conducted in two sequential parts:
- Part 1: MT-3724 dose escalation groups administered in combination with the fixed doses of gemcitabine and oxaliplatin.
- Part 2: MT-3724 Maximum Tolerated Dose expansion treatment group; a given MT-3724 dose will be administered in combination with the fixed doses of gemcitabine and oxaliplatin.
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Have B-cell non-Hodgkin’s lymphoma (NHL) that has returned or is not responding to treatment.
- Have received all approved treatments for NHL and have adequate organ and body functions.
You will be excluded from the study if any of the following criteria apply to you:
- Have evidence of prior cancer less than 2 years before start of treatment.
- Have current evidence of new or growing brain or spinal involvement with your disease.
- Have a history or current evidence of significant cardiovascular disease.
This is a partial list of inclusion and exclusion criteria.