Clinical Trial TitleObinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy in treating patients with relapsed or refractory follicular lymphoma.
Clinical Trial Protocol Description:
Follicular lymphoma (FL) is a cancer of lymphocytes, a type of white blood cell. FL is one form of non-Hodgkin lymphoma (NHL). NHL is the most common type of lymphoma. In FL, the white blood cells grow and survive longer than normal and this can cause problems such as large lymph glands, particularly in the neck, armpit, or groin areas. Some patients with FL develop large tumors in the abdomen. 20% of patients will respond poorly to first-line chemoimmunotherapy for their FL and they account largely for the early deaths in the larger FL population.
The purpose of this study is to compare any good and bad effects of using different drugs in combination with an antibody to treat FL. An antibody is a protein that can recognize and attack foreign objects (antigens) in the body. In this study, the antibody is obinutuzumab. It looks for CD20, an antigen that is found on tumor cells. Two study drugs will be tested in this study: TGR-1202 and lenalidomide. Each of these study drugs may help the immune system fight cancer. During the study, participants will get either obinutuzumab plus TGR-1202, obinutuzumab plus lenalidomide, or obinutuzumab plus the usual approach treatment for their cancer.
Groups 1 and 2 will get treatment on the study for 48 weeks (about 11 months). Group 3 will get treatment on the study for 42 weeks (about 9½ months). At a minimum, participating subjects will go to the doctor’s office every 3 months for the first 2 years, then every six months until 5 years from the time they started the study.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have FL (Grade I, II or IIIa) that is confirmed at initial diagnosis and at relapse (disease return).
- Have received at least 3 cycles of bendamustine as first line therapy for FL.
- Have failed to achieve a complete remission of disease, or have relapsed within 2 years after completing first line bendamustine-containing chemoimmunotherapy (including an anti-CD20 monoclonal antibody), as measured from the last dose of bendamustine.
- Have a whole body or limited whole body PET/CT scan and bone marrow biopsy performed within 42 days prior to registration to the study.
You will be excluded from the study if any of the following criteria apply to you:
- Have clinical evidence of central nervous system involvement by lymphoma, since the proposed treatment strategies are not designed to address CNS involvement adequately.
- Have previously received anthracycline based therapy.
- Have had prior treatment with any PI3K inhibitor, or lenalidomide.
This is a partial list of inclusion and exclusion criteria.