Obinutuzumab-Based Therapy for Follicular Lymphoma

Recruiting at500 trial locations

Overseen by Paul M Barr

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Paul M Barr

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

This trial is for adults with grade I-IIIa follicular lymphoma that has relapsed or is refractory. Eligible participants must have had only one prior chemotherapy regimen, be at least 18 years old, and have adequate organ function. They should not have CNS involvement by lymphoma or previous treatment with PI3K inhibitors or lenalidomide.

Inclusion Criteria

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

I have received anti-CD20 antibody therapy before CHOP or bendamustine treatment.

I've had one round of chemotherapy with CHOP or bendamustine.

Exclusion Criteria

I have never been treated with PI3K inhibitors or lenalidomide.

My lymphoma has not spread to my brain or spinal cord.

Treatment Details

Interventions

• Bendamustine Hydrochloride (Chemotherapy)
• Cyclophosphamide (Chemotherapy)
• Doxorubicin Hydrochloride (Chemotherapy)
• Lenalidomide (Immunomodulatory Agent)
• Obinutuzumab (Monoclonal Antibodies)
• Prednisone (Corticosteroid)
• Umbralisib (PI3K Inhibitor)
• Vincristine Sulfate (Chemotherapy)

Trial Overview The study tests obinutuzumab alone or combined with umbralisib, lenalidomide, or other chemotherapies to see which works best for treating relapsed/refractory follicular lymphoma. It explores how these treatments affect the immune system's ability to fight cancer and stop tumor growth.

Participant Groups

Group I: Arm II (obinutuzumab, lenalidomide) Experimental Treatment 8 Interventions

Patients receive obinutuzumab IV on day 1 and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and ECHO or MUGA during screening, and PET/CT scans and collection of blood throughout the trial.

Group II: Arm I (obinutuzumab, umbralisib) Experimental Treatment 8 Interventions

CLOSED TO ACCRUAL: Patients receive obinutuzumab IV on day 1 and umbralisib PO daily on days 1-28. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and ECHO or MUGA during screening, and PET/CT scans and collection of blood throughout the trial.

Group III: Arm III (obinutuzumab, combination chemotherapy) Active Control 12 Interventions

PRIOR BENDAMUSTINE-BASED CHEMOTHERAPY: Patients receive obinutuzumab IV on day 1, cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, and prednisone PO on days 1-5. Treatment with obinutuzumab repeats every 21 or 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Treatment with combination chemotherapy repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. PRIOR CHOP CHEMOTHERAPY: Patients receive obinutuzumab IV on day 1, and bendamustine IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for up to 6 or 12 cycles (bendamustine and obinutuzumab, respectively) in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and ECHO or MUGA during screening, and PET/CT scans and collection of blood throughout the trial.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School