Ibrutinib + Rituximab for Follicular Lymphoma

Recruiting in Palo Alto (17 mi)

+169 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Pharmacyclics LLC.

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve participants with follicular lymphoma.

Eligibility Criteria

This trial is for adults aged 60 and older with untreated follicular lymphoma, who meet specific health criteria. They should have a certain level of physical fitness (ECOG score 0-2) and their liver and kidneys must work well. People with transformed lymphoma, brain or spinal cord lymphoma, serious heart conditions, or previous treatments for this cancer can't join.

Inclusion Criteria

My liver and kidney functions are within normal ranges.

My cancer can be measured by tests.

I am 70 or older, or I am 60-69 with one or more health conditions.

+4 more

Exclusion Criteria

I have a serious heart condition that is currently causing symptoms.

I have received treatment for follicular lymphoma before.

My cancer affects my brain or spinal cord.

+1 more

Participant Groups

The study tests if adding Ibrutinib to Rituximab therapy extends the time patients live without their cancer getting worse compared to using Rituximab alone. Participants will either receive Ibrutinib plus Rituximab or a placebo (inactive substance) plus Rituximab.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: (Arm A) ibrutinib + rituximabExperimental Treatment2 Interventions

Participants will receive 560mg of ibrutinib and rituximab 375mg/m\^2 weekly x4 with maintenance.

Group II: (Arm B) placebo + rituximabPlacebo Group2 Interventions

Participants will receive placebo and rituximab 375mg/m\^2 weekly x4 with maintenance.

Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Imbruvica for: