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Non-Hodgkin's LymphomaPhase 1/2NCT02723071

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

A Phase 1/2 study testing Ocrelizumab in people with Non-Hodgkin's Lymphoma, run by Hoffmann-La Roche at 23 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin's Lymphoma
What is being tested?
Ocrelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
23 sitesin 6 countries
Study dates
May 2005to Jan 2008
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

23 sites in 6 countries.

23 sites in 6 countries

Canada5 sites

  • Study site

    Edmonton, Alberta, T6G 1Z2

  • Study site

    Halifax, Nova Scotia, B3H 2Y9

  • Study site

    Ottawa, Ontario, K1H 1C4

  • Study site

    Toronto, Ontario, M5G 2M9

  • Study site

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

France5 sites

  • Study site

    Créteil, 94010

  • Study site

    Lille, 59037

  • Study site

    Nantes, 44093

  • Study site

    Pierre-Bénite, 69495

  • Study site

    Rennes, 35033

Other trials in France

Sweden4 sites

  • Study site

    Huddinge, 14186

  • Study site

    Lund, 22185

  • Study site

    Malmö, 20502

  • Study site

    Umeå, 90185

Other trials in Sweden

Australia3 sites

  • Study site

    Melbourne, 3002

  • Study site

    Perth, 6000

  • Study site

    Woolloongabba, 4102

Other trials in Australia

Italy3 sites

  • Study site

    Bergamo, 24127

  • Study site

    Roma, 00161

  • Study site

    Torino, 10126

Other trials in Italy

Switzerland3 sites

  • Study site

    Bern, 3010

  • Study site

    Geneva, 1211

  • Study site

    Lugano, 6900

Other trials in Switzerland

About this study

Official title: An Open-label, Multicentre, Dose-escalating Phase I/II Trial of 3-weekly Ocrelizumab in Patients With Follicular Non-Hodgkin's Lymphoma (NHL)

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

Being tested
Ocrelizumab
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OcrelizumabDrug

    Also called RO4964913

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

Study groups in NCT02723071
Study groupRoleWhat they receive
Cohort A: Ocrelizumab 200 mg/m^2ExperimentalParticipants 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.
Receives: Drug: Ocrelizumab
Cohort B: Ocrelizumab 375 mg/m^2ExperimentalParticipants 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.
Receives: Drug: Ocrelizumab
Cohort C: Ocrelizumab 375/750 mg/m^2ExperimentalParticipants 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.
Receives: Drug: Ocrelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Dose-limiting Toxicity (DLT)

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

Secondary outcomes (11)

  1. Progression-free Survival According to the International Workshop to Standardize Response Criteria for NHL

    Measured: 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)

  2. Event-free Survival According to the International Workshop to Standardize Response Criteria for NHL

    Measured: 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)

  3. Area Under the Plasma Concentration-Time Curve From Time 0 to Day 28 (AUC0-28) of Ocrelizumab

    Measured: 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

  4. Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity AUC(0-inf) of Ocrelizumab

    Measured: 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

  5. Percentage of Participants With Overall Response According to the International Workshop to Standardize Response Criteria for NHL

    Measured: 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. Maximum Plasma Concentration (Cmax) of Ocrelizumab

    Measured: 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

  7. Systemic Clearance (CL) of Ocrelizumab

    Measured: 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

  8. Steady State Volume of Distribution (Vss) of Ocrelizumab

    Measured: 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

  9. Terminal Elimination Half-Life (t1/2) of Ocrelizumab

    Measured: 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

  10. Number of Participants With Peripheral Blood B-cell Depletion

    Measured: 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)

  11. Number of Participants With Peripheral Blood B-cell Recovery

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2016 (estimated)
  2. Study startMay 2005
  3. Primary completionJan 2008
  4. Study completionJan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02723071
Sponsor's protocol ID
BO18414
Other IDs
2004-004110-17, 2004
Status last verified
Mar 2016
First submitted
24 Mar 2016
Last updated
30 Mar 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ocrelizumab in people with Non-Hodgkin's Lymphoma, run by Hoffmann-La Roche at 23 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Canada, France, Sweden, Australia, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose-limiting Toxicity (DLT) (time frame: first cycle (3-week cycle) of Cohort A, Cohort B, and Cohort C). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02723071.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2016.

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