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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-004110-17 | EudraCT Number |
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This study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of ocrelizumab in participants with progressive follicular NHL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocrelizumab | Drug | Participants will receive a total of 8 intravenous (IV) infusions of ocrelizumab given at intervals of 3 weeks, until disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-limiting Toxicity (DLT) | first cycle (3-week cycle) of Cohort A, Cohort B, and Cohort C |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Melbourne | 3002 | Australia | ||||
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| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| 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) |
| Perth |
| 6000 |
| Australia |
| Woolloongabba | 4102 | Australia |
| Edmonton | Alberta | T6G 1Z2 | Canada |
| Vancouver | British Columbia | V5Z 4E6 | Canada |
| Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Ottawa | Ontario | K1H 1C4 | Canada |
| Toronto | Ontario | M5G 2M9 | Canada |
| Créteil | 94010 | France |
| Lille | 59037 | France |
| Nantes | 44093 | France |
| Pierre-Bénite | 69495 | France |
| Rennes | 35033 | France |
| Bergamo | 24127 | Italy |
| Roma | 00161 | Italy |
| Torino | 10126 | Italy |
| Huddinge | 14186 | Sweden |
| Lund | 22185 | Sweden |
| Malmö | 20502 | Sweden |
| Umeå | 90185 | Sweden |
| Bern | 3010 | Switzerland |
| Geneva | 1211 | Switzerland |
| Lugano | 6900 | Switzerland |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C533411 | ocrelizumab |
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