Clinical Trial TitleA phase 2 study of the combination of ublituximab + TGR-1202 and TG-1202 alone in patients with previously treated diffuse large B-cell lymphoma.
Clinical Trial Protocol Description:
Front-line therapy for diffuse large B-cell lymphoma (DLBCL) typically consists of an anthracycline (such as daunorubicin, doxorubicin, or epirubicin) and an anti-CD20 antibody (such as rituximab, which targets B lymphocytes) containing chemotherapy combination. Recurrent disease is the term used to describe disease that returns after an initial remission.
Monoclonal antibodies agents provide a type of targeted therapy directed at specific proteins on the cell surface. Targeted therapies block the growth and spread of cancer by attacking specific cancer cells while minimizing harm to normal cells. Monoclonal antibodies can be used alone or to carry drugs, toxins, or radioactive substances directly to cancer cells. Ublituximab is an anti-CD20 monoclonal antibody that has a unique protein sequence, and targets cell areas on B-cells not targeted by rituximab or ofatumumab.
The phosphoinositide-3-kinase (PI3K) are a family of enzymes involved in various cellular functions, including cell proliferation and survival, cell differentiation, intracellular trafficking and immunity. The delta isoform of PI3K is highly expressed in cells of hematopoietic (formation of blood cells) origin, and strongly upregulated, and often mutated in various hematologic malignancies. TGR-1202 is an oral PI3K delta inhibitor. Previous studies have demonstrated the ability of TGR-1202 safety and effectiveness in treatment for a wide variety of relapsed or refractory blood cancers.
This is a study using the combination of ublituximab and TGR-1202 and TGR-1202 alone in patients whose diffuse large B-cell lymphoma has returned after treatment.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years or older.
- Have relapsed or refractory DLBCL to prior standard therapy AND not be a candidate for high-dose therapy or autologous stem cell transplant.
- Have at least 1 measurable disease lesion greater than 1.5 centimeters in at least one diameter by CT/CT-PET or magnetic resonance imaging (MRI) in an area of no prior radiation therapy, or in an area that was previously irradiated that has documented progression.
- Have the ability to swallow and retain oral medication.
This is a partial list of elgibility requirements.