Study ID: S1608
Obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy in treating patients with relapsed or refractory grade I-IIIa follicular lymphoma
This trial is for patients who have been diagnosed with follicular lymphoma, which is the most common subtype of low-grade lymphoma. It is a B-cell lymphoma characterized by tumor cells that appear in a circular or clump-like pattern when viewed under the microscope.
Researchers seek to determine the best therapy for those who have been treated for follicular lymphoma but their disease has returned. They are testing how well obinutuzumab (Gazyva®), a monoclonal antibody, works with other drugs. It is thought that monoclonal antibodies like obinutuzumab may interfere with the ability of tumor cells to grow and spread. It is not yet known which combination of drugs will work better in treating patients with relapsing or refractory follicular lymphoma.
All study participants are administered obinutuzumab. Participants are randomized into three study groups that receive the additional drugs as noted below:
- Group 1: umbralisib (TGR-1202), an oral medication currently in clinical trials for blood cancers
- Group 2: lenalidomide (Revlimid®), a cancer drug currently approved to treat myelodysplastic syndrome and multiple myeloma
- Group 3: combination chemotherapy
- Follicular lymphoma (grade I, II or IIIa) confirmed at initial diagnosis and at relapse with identifiable FDG avid disease on PET/CT.
- Involvement with large cell lymphoma is ineligible. No clinical evidence of CNS involvement by lymphoma.
- Whole body or limited whole body PET/CT scan performed within 42 days prior to registration. Bone marrow biopsy performed within 42 days prior to registration.
Note: Additional inclusion criteria may apply. Please contact the clinical trials coordinator for more information.
In the absence of disease progression or unacceptable toxicity, patients receive:
- Arm 1: obinutuzumab IV on day 1 and umbralisib PO daily on days 1–28. Treatment repeats every 28 days for up to 12 courses.
- Arm 2: obinutuzumab IV on day 1 and lenalidomide PO on days 1–21. Treatment repeats every 28 days for up to 12 courses.
- Arm 3: obinutuzumab IV on day 1, cyclophosphamide IV over 15 minutes on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone PO on days 1–5. Treatment with obinutuzumab repeats every 21 or 28 days for up to 12 courses. Treatment with combination chemotherapy repeats every 21 days for up to 6 courses.
- Must have already undergone treatment for follicular lymphoma but it has returned