Obinutuzumab + Zanubrutinib for Follicular Lymphoma (ROSEWOOD Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: BeiGene

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing if a combination of two drugs works better than one drug alone for patients with a type of lymphoma that has returned or resisted treatment. One drug stops cancer growth, and the other helps the immune system kill cancer cells.

Eligibility Criteria

This trial is for people with relapsed/refractory non-Hodgkin follicular lymphoma who have had at least two prior treatments, including an anti-CD20 antibody and alkylator therapy. They must have measurable disease, adequate organ function, and a performance status of 0 to 2. Those with aggressive lymphoma transformation, recent major surgery or other cancers (with some exceptions), or past BTK inhibitor treatment can't join.

Inclusion Criteria

My condition worsened after my last treatment or is not responding to treatment.

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

I have had at least 2 treatments for follicular lymphoma.

My cancer can be measured by tests.

I have been treated with an anti-CD20 antibody and a specific chemotherapy.

My diagnosis is B-cell follicular lymphoma.

Exclusion Criteria

I am currently being treated for a serious infection.

I have been treated with a BTK inhibitor before.

I have a serious heart condition.

My follicular lymphoma has changed into a more aggressive type.

I had a stem cell transplant from a donor within the last year.

I have a history of severe bleeding problems.

My leukemia or lymphoma has spread to my brain or spinal cord.

Treatment Details

The study compares the effectiveness of combining Obinutuzumab (a monoclonal antibody) with Zanubrutinib (BGB-3111), a Bruton's tyrosine kinase inhibitor, against using Obinutuzumab alone in participants with refractory/relapsed follicular lymphoma to see which is better at treating the condition.

2Treatment groups

Experimental Treatment

Group I: Zanubrutinib + ObinutuzumabExperimental Treatment2 Interventions

Zanubrutinib 160 mg twice a day orally with or without food; Obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2 to 6; and then every 8 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; each cycle is 28 days

Group II: ObinutuzumabExperimental Treatment1 Intervention

Obinutuzumab 1000 milligrams (mg) intravenously on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2 to 6; and then every 8 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; each cycle is 28 days

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

🇺🇸 Approved in United States as Gazyva for: