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

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ClinicalTrials.gov Identifier: NCT02723071
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: Ocrelizumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : May 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Ocrelizumab

Arm Intervention/treatment
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.
Drug: 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.
Other Name: RO4964913

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.
Drug: 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.
Other Name: RO4964913

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.
Drug: 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.
Other Name: RO4964913




Primary Outcome Measures :
  1. Number of Participants With Dose-limiting Toxicity (DLT) [ Time Frame: first cycle (3-week cycle) of Cohort A, Cohort B, and Cohort C ]

Secondary Outcome Measures :
  1. Progression-free Survival According to the International Workshop to Standardize Response Criteria for NHL [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723071


Locations
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Australia
Melbourne, Australia, 3002
Perth, Australia, 6000
Woolloongabba, Australia, 4102
Canada, Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Ottawa, Ontario, Canada, K1H 1C4
Toronto, Ontario, Canada, M5G 2M9
France
Creteil, France, 94010
Lille, France, 59037
Nantes, France, 44093
Pierre Benite, France, 69495
Rennes, France, 35033
Italy
Bergamo, Italy, 24127
Roma, Italy, 00161
Torino, Italy, 10126
Sweden
Huddinge, Sweden, 14186
Lund, Sweden, 22185
Malmoe, Sweden, 20502
Umea, Sweden, 90185
Switzerland
Bern, Switzerland, 3010
Geneve, Switzerland, 1211
Lugano, Switzerland, 6900
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02723071     History of Changes
Other Study ID Numbers: BO18414
2004-004110-17 ( EudraCT Number )
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Ocrelizumab
Immunologic Factors
Physiological Effects of Drugs