Please note that the ANZCTR will be unattended from Friday the 17th of July to Monday the 20th of July 2020 inclusive. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02723071




Registration number
NCT02723071
Ethics application status
Date submitted
24/03/2016
Date registered
30/03/2016
Date last updated
30/03/2016

Titles & IDs
Public title
A Study of Ocrelizumab in Participants With Follicular Non-Hodgkin's Lymphoma (NHL)
Scientific title
An Open-label, Multicentre, Dose-escalating Phase I/II Trial of 3-weekly Ocrelizumab in Patients With Follicular Non-Hodgkin's Lymphoma (NHL)
Secondary ID [1] 0 0
2004-004110-17
Secondary ID [2] 0 0
BO18414
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ocrelizumab

Experimental: Cohort A: Ocrelizumab 200 mg/m^2 - 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.

Experimental: Cohort B: Ocrelizumab 375 mg/m^2 - 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.

Experimental: Cohort C: Ocrelizumab 375/750 mg/m^2 - 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.


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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Dose-limiting Toxicity (DLT)
Timepoint [1] 0 0
first cycle (3-week cycle) of Cohort A, Cohort B, and Cohort C
Secondary outcome [1] 0 0
Progression-free Survival According to the International Workshop to Standardize Response Criteria for NHL
Timepoint [1] 0 0
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)
Secondary outcome [2] 0 0
Event-free Survival According to the International Workshop to Standardize Response Criteria for NHL
Timepoint [2] 0 0
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)
Secondary outcome [3] 0 0
Area Under the Plasma Concentration-Time Curve From Time 0 to Day 28 (AUC0-28) of Ocrelizumab
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity AUC(0-inf) of Ocrelizumab
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
Percentage of Participants With Overall Response According to the International Workshop to Standardize Response Criteria for NHL
Timepoint [5] 0 0
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)
Secondary outcome [6] 0 0
Maximum Plasma Concentration (Cmax) of Ocrelizumab
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
Systemic Clearance (CL) of Ocrelizumab
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
Steady State Volume of Distribution (Vss) of Ocrelizumab
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
Terminal Elimination Half-Life (t1/2) of Ocrelizumab
Timepoint [9] 0 0
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
Secondary outcome [10] 0 0
Number of Participants With Peripheral Blood B-cell Depletion
Timepoint [10] 0 0
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)
Secondary outcome [11] 0 0
Number of Participants With Peripheral Blood B-cell Recovery
Timepoint [11] 0 0
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)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Melbourne
Recruitment hospital [2] 0 0
- Perth
Recruitment hospital [3] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
3002 - Melbourne
Recruitment postcode(s) [2] 0 0
6000 - Perth
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Nova Scotia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
France
State/province [5] 0 0
Creteil
Country [6] 0 0
France
State/province [6] 0 0
Lille
Country [7] 0 0
France
State/province [7] 0 0
Nantes
Country [8] 0 0
France
State/province [8] 0 0
Pierre Benite
Country [9] 0 0
France
State/province [9] 0 0
Rennes
Country [10] 0 0
Italy
State/province [10] 0 0
Bergamo
Country [11] 0 0
Italy
State/province [11] 0 0
Roma
Country [12] 0 0
Italy
State/province [12] 0 0
Torino
Country [13] 0 0
Sweden
State/province [13] 0 0
Huddinge
Country [14] 0 0
Sweden
State/province [14] 0 0
Lund
Country [15] 0 0
Sweden
State/province [15] 0 0
Malmoe
Country [16] 0 0
Sweden
State/province [16] 0 0
Umea
Country [17] 0 0
Switzerland
State/province [17] 0 0
Bern
Country [18] 0 0
Switzerland
State/province [18] 0 0
Geneve
Country [19] 0 0
Switzerland
State/province [19] 0 0
Lugano

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy
of ocrelizumab in participants with progressive follicular NHL.
Trial website
https://clinicaltrials.gov/show/NCT02723071
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications