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

Phase 1

Completed

• Conditions: Non-Hodgkin's Lymphoma
• Interventions: Drug: Ocrelizumab

• Registration Number: NCT02723071
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of ocrelizumab in participants with progressive follicular NHL.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2016-03
• Study First Submitted: 2016-03-24
• Study First Submitted QC: 2016-03-24
• Last Update Submitted: 2016-03-24
• Study First Posted: 2016-03-30
• Last Update Posted: 2016-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• 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
• No evidence of hepatitis B or C

Exclusion Criteria

• Prior monoclonal antibody therapy other than rituximab, anti-cancer vaccine, or radioimmunotherapy for cancer
• History of severe allergic or anaphylactic reaction to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products
• Major nondiagnostic surgery within 4 weeks of Screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A: Ocrelizumab 200 mg/m^2	Ocrelizumab	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.
Cohort B: Ocrelizumab 375 mg/m^2	Ocrelizumab	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.
Cohort C: Ocrelizumab 375/750 mg/m^2	Ocrelizumab	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Dose-limiting Toxicity (DLT)	first cycle (3-week cycle) of Cohort A, Cohort B, and Cohort C

Secondary Outcome Measures

Name	Time	Method
Steady State Volume of Distribution (Vss) of Ocrelizumab	Pre-infusion (0-2 hours); 30 minutes post infusion on Day 1 of Cycles 1 to 8 (Cycle length = 21 days); Days 2, 8, and 15 of Cycle 1 (Cohorts A, B), Cycle 2 (Cohort C), and Cycle 8 (Cohorts A, B, C); Days 176, 190, 204, 259, 322, 357, 539
Number of Participants With Peripheral Blood B-cell Recovery	Week 24, 28 days following the final infusion (Day 176), 9, 18, 24, and 30 months after study entry or until B cell recovery, whichever occurred first (up to approximately 2.75 years)
Progression-free Survival According to the International Workshop to Standardize Response Criteria for NHL	Day 1, after 4 and 8 cycles of therapy (12 and 24 weeks after study entry) until disease progression/relapse, or death, whichever occurred first (overall up to approximately 2.75 years)
Event-free Survival According to the International Workshop to Standardize Response Criteria for NHL	Day 1, after 4 and 8 cycles of therapy (12 and 24 weeks after study entry) until disease progression/relapse, or death, whichever occurred first (overall up to approximately 2.75 years)
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity AUC(0-inf) of Ocrelizumab	Pre-infusion (0-2 hours); 30 minutes post infusion on Day 1 of Cycles 1 to 8 (Cycle length = 21 days); Days 2, 8, and 15 of Cycle 1 (Cohorts A, B), Cycle 2 (Cohort C), and Cycle 8 (Cohorts A, B, C); Days 176, 190, 204, 259, 322, 357, 539
Area Under the Plasma Concentration-Time Curve From Time 0 to Day 28 (AUC0-28) of Ocrelizumab	Pre-infusion (0-2 hours); 30 minutes post infusion on Day 1 of Cycles 1 to 8 (Cycle length = 21 days); Days 2, 8, and 15 of Cycle 1 (Cohorts A, B), Cycle 2 (Cohort C), and Cycle 8 (Cohorts A, B, C); Days 176, 190, 204, 259, 322, 357, 539
Percentage of Participants With Overall Response According to the International Workshop to Standardize Response Criteria for NHL	Day 1, after 4 and 8 cycles of therapy (12 and 24 weeks after study entry) until disease progression/relapse, or death, whichever occurred first (overall up to approximately 2.75 years)
Systemic Clearance (CL) of Ocrelizumab	Pre-infusion (0-2 hours); 30 minutes post infusion on Day 1 of Cycles 1 to 8 (Cycle length = 21 days); Days 2, 8, and 15 of Cycle 1 (Cohorts A, B), Cycle 2 (Cohort C), and Cycle 8 (Cohorts A, B, C); Days 176, 190, 204, 259, 322, 357, 539
Number of Participants With Peripheral Blood B-cell Depletion	Week 24, 28 days following the final infusion (Day 176), 9, 18, 24, and 30 months after study entry or until B cell recovery, whichever occurred first (up to approximately 2.75 years)
Maximum Plasma Concentration (Cmax) of Ocrelizumab	Pre-infusion (0-2 hours); 30 minutes post infusion on Day 1 of Cycles 1 to 8 (Cycle length = 21 days); Days 2, 8, and 15 of Cycle 1 (Cohorts A, B), Cycle 2 (Cohort C), and Cycle 8 (Cohorts A, B, C); Days 176, 190, 204, 259, 322, 357, 539
Terminal Elimination Half-Life (t1/2) of Ocrelizumab	Pre-infusion (0-2 hours); 30 minutes post infusion on Day 1 of Cycles 1 to 8 (Cycle length = 21 days); Days 2, 8, and 15 of Cycle 1 (Cohorts A, B), Cycle 2 (Cohort C), and Cycle 8 (Cohorts A, B, C); Days 176, 190, 204, 259, 322, 357, 539