Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma

Running, not enrolling · Phase 2

Conditions studied: Grade 1 Follicular Lymphoma, Grade 2 Follicular Lymphoma, Grade 3a Follicular Lymphoma, Recurrent Follicular Lymphoma, Refractory Follicular Lymphoma

In brief

This phase II trial studies how well obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy work in treating patients with grade I-IIIa follicular lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Chemotherapy drugs, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy will work better in treating patients with grade I-IIIa follicular lymphoma.

Key facts

Study ID: NCT03269669
Run by: National Cancer Institute (NCI)
People needed: 73
Starts: 2018-01-23
Expected to finish: 2027-01-21
Last updated by the study team: 2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have follicular lymphoma (grade I, II or IIIa) confirmed at initial diagnosis and at relapse with identifiable fludeoxyglucose F-18 (FDG) avid disease on PET/CT; patients that have involvement with large cell lymphoma are not eligible
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
Patients must have an indication for therapy as determined by the treating investigator
All disease must be assessed and documented on the S1608 FDG-PET/CT assessment form
The intent is to enroll patients with follicular lymphoma (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 of bendamustine is required)
Patients who received any anti-CD20 antibody therapy prior to CHOP or bendamustine are eligible
Patients who additionally received any maintenance anti-CD-20 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 ibritumomab 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 prior treatment related toxicities (except alopecia) must have resolved to grade 1 or less prior to registration
Patients must have tissue specimens collected prior to registration; patients must be offered participation in biobanking of residual specimens; with patient consent, residuals from the mandatory submission(s) will be banked for future research
Patients must be >= 18 years of age
All patients must have a Zubrod performance status of 0, 1 or 2
Absolute neutrophil count (ANC) >= 1,500/mcL within 28 days prior to registration
Platelets >= 75,000/mcL within 28 days prior to registration
Patients must have adequate renal function as documented by a calculated creatinine clearance >= 60 mL/min, within 28 days prior to registration
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (=< 5 x IULN if secondary to lymphoma, Gilbert's syndrome, or medication related [e.g., indinavir, tenofovir, atazanavir]) within 28 days prior to registration
Direct bilirubin =< 1.5 x IULN (=< 5 x IULN if secondary to lymphoma) within 28 days prior to registration

You may not qualify if…

Patients must not have clinical evidence of central nervous system involvement by lymphoma since the proposed treatment strategies are not designed to address central nervous system (CNS) involvement adequately; if performed, any laboratory or radiographic tests performed to assess CNS involvement must be negative
Patients must not have any prior treatment with any PI3K inhibitor, or lenalidomide

Where it is running

Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States
Alaska Women's Cancer Care — Anchorage, Alaska, United States
Anchorage Oncology Centre — Anchorage, Alaska, United States
Katmai Oncology Group — Anchorage, Alaska, United States
Providence Alaska Medical Center — Anchorage, Alaska, United States
Banner University Medical Center - Tucson — Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
Kaiser Permanente-Anaheim — Anaheim, California, United States
Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States
PCR Oncology — Arroyo Grande, California, United States
Sutter Auburn Faith Hospital — Auburn, California, United States
Kaiser Permanente-Baldwin Park — Baldwin Park, California, United States
Kaiser Permanente-Bellflower — Bellflower, California, United States
Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
City of Hope Comprehensive Cancer Center — Duarte, California, United States
Kaiser Permanente Dublin — Dublin, California, United States
Kaiser Permanente-Fontana — Fontana, California, United States
Kaiser Permanente-Fremont — Fremont, California, United States
Kaiser Permanente-Fresno — Fresno, California, United States
Kaiser Permanente South Bay — Harbor City, California, United States
City of Hope Seacliff — Huntington Beach, California, United States
City of Hope at Irvine Lennar — Irvine, California, United States
Kaiser Permanente-Irvine — Irvine, California, United States
Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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