A Study of Ocrelizumab in Participants With Follicular Non-Hodgkin's Lymphoma (NHL)

Recruiting in Palo Alto (17 mi)

+22 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of ocrelizumab in participants with progressive follicular NHL.

Eligibility Criteria

Inclusion Criteria

No evidence of hepatitis B or C

Follicular NHL

Documented history of response, or stable disease more than 6 months in duration, to a rituximab-containing regimen that was the last treatment before enrollment in the study

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Cohort C: Ocrelizumab 375/750 mg/m^2Experimental Treatment1 Intervention

Participants will receive first infusion of ocrelizumab 375 mg/m\^2 followed by 7 infusions of 750 mg/m\^2 given at intervals of 3 weeks, until disease progression or unacceptable toxicity.

Group II: Cohort B: Ocrelizumab 375 mg/m^2Experimental Treatment1 Intervention

Participants will receive a total of 8 infusions of ocrelizumab 375 mg/m\^2 given at intervals of 3 weeks, until disease progression or unacceptable toxicity.

Group III: Cohort A: Ocrelizumab 200 mg/m^2Experimental Treatment1 Intervention

Participants will receive a total of 8 infusions of ocrelizumab 200 milligram per square meter (mg/m\^2) given at intervals of 3 weeks, until disease progression or unacceptable toxicity.

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

🇺🇸 Approved in United States as Ocrevus for: