Clinical Trial Information
Protocol – SWOG – S1608
Please Note – Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.
- Patients must have follicular lymphoma (Grade I, II or IIIa) confirmed at initial diagnosis and at relapse with identifiable FDG avid disease on PET/CT. Patients that have involvement with large cell lymphoma are not eligible.
- Patients must not have clinical evidence of central nervous system involvement by lymphoma, since the proposed treatment strategies are not designed to address CNS involvement adequately. If performed, any laboratory or radiographic tests performed to assess CNS involvement must be negative.
- Patients must have a whole body or limited whole body PET/CT scan performed within 42 days prior to registration.
- Patients must have bone marrow biopsy performed within 42 days prior to registration.
- The intent is to enroll patients with FL relapsed within 2 years of completing their first course of chemotherapy (CHOP or bendamustine based therapy) + anti-CD20 therapy. Patient is still eligible if he/she received radiation therapy or anti-CD20 therapy prior to chemoimmunotherapy or if maintenance anti-CD20 therapy was administered after chemoimmunotherapy.
- Patients must have either failed to achieve a complete remission, or must have relapsed within 2 years after completing CHOP or bendamustine-containing chemoimmunotherapy (including an anti-CD20 monoclonal antibody), as measured from the last dose of CHOP or bendamustine
- Relapsed patients must not have received any intervening chemotherapy. Patients must have received only 1 course of chemotherapy, containing at least 3 cycles of CHOP or bendamustine. (Note that no minimum dose is required.).
- Patients who received any anti-CD20 antibody therapy prior to CHOP or bendamustine are eligible.
- Patients who additionally received any maintenance anti-CD20 antibody therapy or consolidative radioimmunotherapy within 2 years of the last dose of the CHOP or bendamustine therapy are eligible.
- Involved field or involved site radiation is not considered a line of therapy.
- Examples of eligible prior treatment regimens (note this list is not all inclusive):
- 1st line Rituximab treatment followed years later by bendamustine rituximab.
- Bendamustine rituximab x 4 cycles.
- 1st line rituximab treatment, 2nd line ibrutumomab tiuxetan, followed by bendamustine bortezomib rituximab x 6 cycles followed by rituximab maintenance.
- Bendamustine obinutuzumab x 3 cycles.
- CHOP rituximab x 6 cycles followed by rituximab maintenance
- For all forms of systemic therapy, patients must have completed therapy at least 21 days prior to registration. Patients must have completed any radioimmunotherapy at least 84 days prior to registration. Patients must have recovered from all treatment related toxicities from these therapies prior to registration.
- Patients must not have any prior treatment with any PI3K inhibitor, or lenalidomide.
- Patients must be able to discontinue CYP2C9 substrates with a narrow therapeutic index (e.g. warfarin, phenytoin), if randomized to TGR-1202. Patients must discontinue such agents at least 1 week or 5 half-lives prior to beginning protocol therapy (whichever is longer). A list of 2C9 substrates is available at http://medicine.iupui.edu/clinpharm/ddis/main-table/. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference.
- No second prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for three years.