Obinutuzumab-Based Therapy for Follicular Lymphoma

Recruiting in Palo Alto (17 mi)

+493 other locations

Overseen ByPaul 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.

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

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

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

I have managed hepatitis B or C, or HIV with no liver damage.

I had a full medical check-up in the last 28 days.

I have grade I, II, or IIIa follicular lymphoma with FDG-avid disease, and no large cell lymphoma involvement.

My cancer returned or didn't fully respond within 2 years after my last CHOP or bendamustine treatment, without any other chemotherapy in between.

My kidney function is good, with a creatinine clearance rate of at least 60 mL/min.

I can take care of myself and am up and about more than 50% of my waking hours.

I am willing and able to take blood clot prevention medication if needed.

I am 18 years old or older.

My heart's pumping ability is confirmed to be good by a recent heart scan.

Exclusion Criteria

I have never been treated with PI3K inhibitors or lenalidomide.

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

Participant Groups

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.

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (obinutuzumab, lenalidomide)Experimental Treatment8 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 Treatment8 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 Control12 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.

Obinutuzumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Gazyva for: