Chronic Lymphocytic Leukemia Treatment Study
This is a phase 3 study to test how effective the combination of two investigational drugs, ublituximab and TGR-1202, is in comparison to the combination of two FDA approved drugs, obinutuzumab and chlorambucil, as well as in comparison to ublituximab and TGR-1202 when used alone to treat patients with chronic lymphocytic leukemia.
In order to participate you must meet the following criteria:
- Have B-cell CLL that warrants treatment.
- Have evidence of progressive marrow failure as manifested by the onset or worsening of anemia and/or thrombocytopenia.
- Have massive, progressive, or symptomatic enlargement of the spleen; massive, progressive, or symptomatic lymphadenopathy; progressive lymphocytosis in the absence of infection; lymphocyte doubling time of less than 6 months.
- Have autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy.
- Have adequate organ system function.
- Have a ECOG performance status less than or equal to 2.
- Have the ability to swallow and retain oral medication.
You will be excluded from the study if any of the following criteria apply to you:
- Are receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) or any investigational drug within 21 days of randomization.
- Have had autologous hematologic stem cell transplant within 3 months of study entry.
- Have evidence of chronic active hepatitis B, chronic active hepatitis C infection, cytomegalovirus, or known history of HIV.
- Have a known histological transformation from CLL to an aggressive lymphoma (Richter’s transformation).
- Have prior exposure to idelalisib, duvelisib, ACP-319, or any drug that specifically inhibits phosphoinositide-3-kinase (PI3K).
- Have received prior therapy with obinutuzumab and/or chlorambucil.
This is a partial list of inclusion and exclusion criteria.