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Protocol No. S1608

Principal Investigator Kenkre, Vaishalee

Phase II

Age Group Adult

Scope National

Sponsor Type National

Title Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma

The purpose of this study is to compare any good and bad effects of using different drugs in combination with an antibody.
An antibody is a protein that can recognize and attack foreign objects (antigens) in the body.
Here, the antibody is obinutuzumab. It is looking 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, you will get either obinutuzumab plus TGR-1202, obinutuzumab plus lenalidomide, or obinutuzumab plus the usual approach treatment for your cancer.
The addition of TGR-1202 or lenalidomide could shrink your cancer, but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the addition of a study drug should increase the chances of your cancer shrinking by about 45% compared to the usual approach. The antibody (obinutuzumab) and the regular chemotherapy approach are FDA-approved for use in follicular lymphoma, but they aren’t usually used together. The immune system drug. TGR-1202 is not FDA approved. The immune system drug lenalidomide is FDA approved, but not for follicular lymphoma (your type of cancer).

Arm 1:
  • Obinutuzumab 1000 mg intravenously on day 1 of every cycle with TGR-1202 800 mg orally daily every cycle for a total of 12 cycles each cycle is 28 days
    Arm 2:
  • Obinutuzumab 1000 mg intravenously on day 1 of every cycle with Lenalidomide 20 mg orally daily days 1-21 of every cycle each cycle is 28 days
    Arm 3:
  • Obinutuzumab 1000 mg intravenously on day 1 of every cycle for 12 cycles PLUS
  • CHOP(cycles 1-6)
  • Cyclophosphamide 750 mg/m2 intravenously over 15 minutes on day 1, Doxorubicin 50 mg/m2 intravenously on day 1, Vincristine 1.4 mg/m2 intravenously on day 1 and Prednisone 100 mg orally days 1-5
  • Cycles 1-6 are 21 days and cycles 7-12 are 28 days

  • Description Randomized Phase II study using Obinutuzumab, TGR-1202, Lenalidomide and CHOP for patients with Early Relapsing or Refractory Follicular Cancer

    Key Eligibility
  • Patients must have follicular lymphoma (Grade I, II or IIIa)
  • Patients that have involvement with large cell lymphoma are not eligible
  • Patients must have either failed to achieve a complete remission, or must have relapsed within 2 years after completing first line bendamustine containing chemoimmunotherapy
  • Patients must have received at least 3 cycles of bendamustine as first line therapy
  • Patients who additionally received any maintenance anti-CD-20 antibody based therapy or consolidative radioimmunotherapy within 2 years of the last dose of the bendamustine therapy are eligible
  • Patients who previously received anthracycline based therapy are excluded
  • Patients must not have any prior treatment with any PI3K inhibitor, or lenalidomide
  • Zubrod performance status of 0, 1 or 2
  • Adequate bone marrow, hepatic and renal function
  • Ejection fraction greater than or equal to 45%
  • Patients must be able and willing to receive prophylaxis with daily aspirin, low molecular weight heparin, factor X inhibitors or Warfarin if randomized to lenalidomide.
  • Patients must also be willing to receive pneumocysitis jirovecii prophylaxis with sulfamethoxazole/trimethoprim, dapsone, atovaquone or inhaled pentamadine, in the event that they are randomized to TGR-1202
  • No secondary malignancy unless disease free for 3 years

  • Applicable Disease Sites Lymphoma

    Status Open

    Participating Institutions Swedish American Hospital, Rockford ; UW Hospital and Clinics; UWCCC 1 South Park