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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-008490-60 |
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This 2 stage study will compare the pharmacokinetics and safety profile of subcutaneous and intravenous rituximab in participants with follicular lymphoma. In the first stage, participants who have achieved at least a partial response after induction treatment with intravenous rituximab will be randomized to one of 3 treatment cohorts, to receive rituximab 375 milligram per square meter (mg/m^2) intravenously, 375 mg/m^2 subcutaneously or 625 mg/m^2 subcutaneously, and pharmacokinetics evaluated on an ongoing basis. Upon selection of the subcutaneous dose (800 mg/m^2) which results in rituximab trough plasma concentration (C trough) values comparable to those achieved with the intravenous formulation, participants in the second stage of the study will be randomized to receive either the subcutaneous or intravenous formulation to demonstrate comparability of the C trough levels with both routes of administration. Maintenance therapy will continue every 2 or 3 months with the subcutaneous formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab IV 375 mg/m^2 (Stage 1: Cohort A) | Active Comparator |
| |
| Rituximab IV 375 mg/m^2 (Stage 2: Cohort E) | Active Comparator |
| |
| Rituximab SC 1400 mg (Stage 2: Cohort F) | Experimental |
| |
| Rituximab SC 375 mg/m^2 (Stage 1: Cohort B) | Experimental |
| |
| Rituximab SC 625 mg/m^2 (Stage 1: Cohort C) | Experimental |
| |
| Rituximab SC 800 mg/m^2 (Stage 1: Cohort D) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Rituximab subcutaneous injection at 1400 mg dose level, administered every 2 or 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Minimum Observed Plasma Trough Concentration (C trough) | Up to 29 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to end of Dosing Interval (AUCtau) | Up to 29 months | |
| Maximum Observed Plasma Concentration (Cmax) | Up to 29 months | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |
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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 |
|---|---|---|---|---|---|---|
| Buenos Aires | 1425 | Argentina | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24821885 | Derived | Salar A, Avivi I, Bittner B, Bouabdallah R, Brewster M, Catalani O, Follows G, Haynes A, Hourcade-Potelleret F, Janikova A, Larouche JF, McIntyre C, Pedersen M, Pereira J, Sayyed P, Shpilberg O, Tumyan G. Comparison of subcutaneous versus intravenous administration of rituximab as maintenance treatment for follicular lymphoma: results from a two-stage, phase IB study. J Clin Oncol. 2014 Jun 10;32(17):1782-91. doi: 10.1200/JCO.2013.52.2631. Epub 2014 May 12. | |
| 24265828 |
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| Rituximab | Drug | Rituximab subcutaneous injection at 800 mg/m^2 dose level, administered every 2 or 3 months. |
|
|
| Rituximab | Drug | Rituximab subcutaneous injection 625 mg/m^2 administered every 2 or 3 months. |
|
|
| Rituximab | Drug | Rituximab intravenous infusion 375 milligram per square meter (mg/m^2) administered every 2 or 3 months. |
|
|
| Rituximab | Drug | Rituximab subcutaneous injection 375 mg/m^2 administered every 2 or 3 months. |
|
|
| Up to 29 months |
| Plasma Decay Half-Life (t1/2) | Up to 29 months |
| Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) | Up to 29 months |
| Buenos Aires |
| C1114AAN |
| Argentina |
| Buenos Aires | C1221ADC | Argentina |
| Córdoba | 5000 | Argentina |
| Rosario | 2000 | Argentina |
| Kogarah | New South Wales | 2217 | Australia |
| Sydney | New South Wales | 2139 | Australia |
| Kurralta Park | South Australia | 5037 | Australia |
| Fitzroy | Victoria | 3065 | Australia |
| Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Barretos | SĆ£o Paulo | 14784-400 | Brazil |
| SĆ£o Paulo | SĆ£o Paulo | 05403-000 | Brazil |
| SĆ£o Paulo | SĆ£o Paulo | 05652-000 | Brazil |
| Calgary | Alberta | T2N 4N2 | Canada |
| St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Montreal | Quebec | H3T 1E2 | Canada |
| QuƩbec | Quebec | G1J 1Z4 | Canada |
| Brno | 625 00 | Czechia |
| Hradec KrƔlovƩ | 500 05 | Czechia |
| Prague | 128 08 | Czechia |
| Herlev | 2730 | Denmark |
| Guayaquil | EC090114 | Ecuador |
| Quito | 2569 | Ecuador |
| Helsinki | 00029 | Finland |
| Tampere | 33520 | Finland |
| Turku | 20520 | Finland |
| Marseille | 13273 | France |
| Montpellier | 34295 | France |
| Reims | 51092 | France |
| Haifa | 3109601 | Israel |
| Jerusalem | 9112001 | Israel |
| Petah Tikva | 49100 | Israel |
| Ramat Gan | 52662 | Israel |
| Bergamo | Lombardy | 24127 | Italy |
| Milan | Lombardy | 20162 | Italy |
| Turin | Piedmont | 10126 | Italy |
| Pisa | Tuscany | 56100 | Italy |
| Aguascalientes | 20127 | Mexico |
| Mexico City, Distrito Federal | 14050 | Mexico |
| Monterrey | 64460 | Mexico |
| Oslo | 0379 | Norway |
| Lima | 11 | Peru |
| Lima | 34 | Peru |
| Warsaw | 02 776 | Poland |
| Wroclaw | 50-367 | Poland |
| Moscow | 115478 | Russia |
| Bratislava | 833 10 | Slovakia |
| Seoul | 135-710 | South Korea |
| Barcelona | Barcelona | 08003 | Spain |
| Barcelona | Barcelona | 08036 | Spain |
| Salamanca | Salamanca | 37007 | Spain |
| Seville | Sevilla | 41013 | Spain |
| Huddinge | 14186 | Sweden |
| Sundsvall | 85186 | Sweden |
| UmeƄ | 90185 | Sweden |
| Uppsala | 75185 | Sweden |
| Basel | 4031 | Switzerland |
| Cambridge | CB2 0QQ | United Kingdom |
| London | EC1A 7BE | United Kingdom |
| Manchester | M20 4QL | United Kingdom |
| Nottingham | NG5 1PB | United Kingdom |
| Derived |
| Mao CP, Brovarney MR, Dabbagh K, Birnbock HF, Richter WF, Del Nagro CJ. Subcutaneous versus intravenous administration of rituximab: pharmacokinetics, CD20 target coverage and B-cell depletion in cynomolgus monkeys. PLoS One. 2013 Nov 12;8(11):e80533. doi: 10.1371/journal.pone.0080533. eCollection 2013. |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| 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 |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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