NCT02723071

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2005

Typical duration for phase_1

Geographic Reach
6 countries

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
8.2 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

2.7 years

First QC Date

March 24, 2016

Last Update Submit

March 24, 2016

Conditions

Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Dose-limiting Toxicity (DLT)

    first cycle (3-week cycle) of Cohort A, Cohort B, and Cohort C

Secondary Outcomes (11)

  • 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 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

  • 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

  • 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)

  • +6 more secondary outcomes

Study Arms (3)

Cohort A: Ocrelizumab 200 mg/m^2

EXPERIMENTAL

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.

Drug: Ocrelizumab

Cohort B: Ocrelizumab 375 mg/m^2

EXPERIMENTAL

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.

Drug: Ocrelizumab

Cohort C: Ocrelizumab 375/750 mg/m^2

EXPERIMENTAL

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.

Drug: Ocrelizumab

Interventions

OcrelizumabDRUG

Participants will receive a total of 8 intravenous (IV) infusions of ocrelizumab given at intervals of 3 weeks, until disease progression or unacceptable toxicity.

Also known as: RO4964913
Cohort A: Ocrelizumab 200 mg/m^2Cohort B: Ocrelizumab 375 mg/m^2Cohort C: Ocrelizumab 375/750 mg/m^2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Unknown Facility

Melbourne, 3002, Australia

Location

Unknown Facility

Perth, 6000, Australia

Location

Unknown Facility

Woolloongabba, 4102, Australia

Location

Unknown Facility

Edmonton, Alberta, T6G 1Z2, Canada

Location

Unknown Facility

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Unknown Facility

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Unknown Facility

Ottawa, Ontario, K1H 1C4, Canada

Location

Unknown Facility

Toronto, Ontario, M5G 2M9, Canada

Location

Unknown Facility

Créteil, 94010, France

Location

Unknown Facility

Lille, 59037, France

Location

Unknown Facility

Nantes, 44093, France

Location

Unknown Facility

Pierre-Bénite, 69495, France

Location

Unknown Facility

Rennes, 35033, France

Location

Unknown Facility

Bergamo, 24127, Italy

Location

Unknown Facility

Roma, 00161, Italy

Location

Unknown Facility

Torino, 10126, Italy

Location

Unknown Facility

Huddinge, 14186, Sweden

Location

Unknown Facility

Lund, 22185, Sweden

Location

Unknown Facility

Malmo, 20502, Sweden

Location

Unknown Facility

Umeå, 90185, Sweden

Location

Unknown Facility

Bern, 3010, Switzerland

Location

Unknown Facility

Geneva, 1211, Switzerland

Location

Unknown Facility

Lugano, 6900, Switzerland

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2016

First Posted

March 30, 2016

Study Start

May 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

March 30, 2016

Record last verified: 2016-03

Locations

CA(5)IT(3)AU(3)CH(3)SE(4)FR(5)