SWOG clinical trial number
S1608

Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma

Open
Phase
Accrual
29%
Abbreviated Title
Randomized Ph II for Relapsed Refractory FL
Status Notes
Re-activation Effective December 15, 2019.

11/1/2018 - A Physician Protocol Card and Physician Handout, reflecting changes made with Revision 3 are now accessible from the protocol abstract page below and will be posted to CTSU protocol abstract page at www.ctsu.org.

Effective with release of Revision #3 (10/2/2018):

The intent of Revision #3 is to provide increased opportunity for accrual. The revision expands the eligibility criteria to include follicular lymphoma patients that relapsed within 2 years of completing their first course of chemotherapy (1 course, containing at least 3 cycles of either CHOP or bendamustine-based therapy) + anti-CD20 therapy.

Arm 3 treatment will now be comprised of either CHOP + Obinutuzumab or Bendamustine + Obinutuzumab. That is, the Arm 3 treatment regimen is dependent upon the first course of chemotherapy that the patient received prior to registration to S1608.

Patients who were treated with bendamustine prior to registration (and who are randomized to Arm 3) will receive CHOP + Obinutuzumab. Conversely, patients who were treated with CHOP prior to registration (and who are randomized to Arm 3) will receive Bendamustine + Obinutuzumab.
Activated
08/10/2017
Participants
US INSTITUTIONS ONLY, ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Research committees

Lymphoma

Treatment

Cyclophosphamide Prednisone Vincristine Doxorubicin CC-5013 (Lenalidomide) Bendamustine Obinutuzumab TGR-1202 CHOP

Eligibility Criteria Expand/Collapse

* Pts must have Grade I, II or IIIa follicular lymphoma (initial diagnosis and relapse) with PET/CT identifiable FDG avid disease.
* No large cell lymphoma involvement allowed.
* No clinical evidence of CNS involvement by lymphoma allowed. If performed, any tests to assess CNS involvement must be negative.
* Pts must have a whole body or limited whole body PET/CT scan within 42 days prior to reg.
* Pts must have BM bx within 42 days prior to reg.
* 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
* Any systemic therapy must be completed at least 21 days prior to reg; any radioimmunotherapy at least 84 days prior to reg. Pts must have recovered from all treatment related toxicities prior to reg.
* No prior PI3K inhibitor or lenalidomide allowed.
* Pts must have blood and tissue specimens collected prior to reg and submitted per Section 15.1. Patients must be offered participation in biobanking of residual specimens, as outlined in Section 15.1e. With patient consent, residuals from the mandatory submission(s) will be banked for future research. Note: See Section 15.1d for information regarding pre-ordering of blood specimen kits for pre-treatment samples.
* Pts must be >/= 18 years of age.
* Pts must have a Zubrod PS of 0, 1 or 2.
* Pts must have adequate BM function ( ANC >/= 1,500/mcL and platelets >/= 75,000/mcL) within 28 days prior to reg.
* Pts must have adequate renal function (calc CrCl >/= 60 mL/min) within 28 days prior to reg.
* Pts must have adequate hepatic function within 28 days prior to reg: total bili </= 1.5 x IULN (</= 5 x IULN if secondary to lymphoma, Gilbert�s syndrome, or medication related); and Direct bili </= 1.5 x IULN (</= 5 x IULN if secondary to lymphoma); and AST and ALT </= 2.5 x IULN (</= 5 x IULN secondary to lymphoma)]
* Pts must have an ECG or MUGA within 42 days prior to reg with cardiac ejection fraction >/= 45%.
* Pts with Hep B must have undetectable HBV on suppressive therapy and no evidence of HBV-related hepatic damage.
Pts with Hep C are eligible if complete eradication therapy has been successfully completed, and there is no detectable HVC or related hepatic damage.
* Pts with known HIV are eligible if they meet all the criteria specified in Section 5.4g. in addition to the other protocol eligibility criteria.
* Pts 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. Patients unable or unwilling to take any listed prophylaxis are NOT eligible.
* Pts must be able to discontinue CYP2C9 substrates with a narrow therapeutic index if randomized to TGR-1202, and must discontinue at least 1 week or 5 half-lives prior to beginning protocol therapy (whichever is longer).
* 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 pt has been disease free for 3 years.
* Pts must have a complete H&P within 28 days prior to reg.
* FCBP must have a negative pregnancy test (sensitivity >/= 25 mIU/mL) within 10 - 14 days and again within 24 hours prior to starting lenalidomide and agree to acceptable methods of birth control (specified in Section 5.4l).
* Patients must have LDH and beta-2-microglobulin collected within 28 days prior to registration.

Reports & Approvals

Trial Locations