A Pharmacokinetic Study of Subcutaneous and Intravenous Rituximab in Participants With Follicular Lymphoma
A Two Stage Phase Ib Study to Investigate the Pharmacokinetics, Safety and Tolerability of Rituximab Subcutaneous (SC) Formulation in Patients With Follicular Lymphoma (FL) as Part of Maintenance Treatment
2 other identifiers
interventional
281
22 countries
62
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2009
Longer than P75 for phase_1
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2009
CompletedFirst Posted
Study publicly available on registry
June 30, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedNovember 2, 2016
November 1, 2016
3.8 years
June 16, 2009
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Minimum Observed Plasma Trough Concentration (C trough)
Up to 29 months
Secondary Outcomes (5)
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)
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
Study Arms (6)
Rituximab IV 375 mg/m^2 (Stage 1: Cohort A)
ACTIVE COMPARATORRituximab IV 375 mg/m^2 (Stage 2: Cohort E)
ACTIVE COMPARATORRituximab SC 1400 mg (Stage 2: Cohort F)
EXPERIMENTALRituximab SC 375 mg/m^2 (Stage 1: Cohort B)
EXPERIMENTALRituximab SC 625 mg/m^2 (Stage 1: Cohort C)
EXPERIMENTALRituximab SC 800 mg/m^2 (Stage 1: Cohort D)
EXPERIMENTALInterventions
Rituximab subcutaneous injection at 1400 mg dose level, administered every 2 or 3 months.
Eligibility Criteria
You may qualify if:
- CD20-positive follicular non-Hodgkin's lymphoma (NHL)
- Documented partial or complete response a the end of induction treatment with rituximab
- Must have completed induction treatment, and received at least 1 dose of intravenous rituximab maintenance treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of less than and equal to (\<=) 2
- Life expectancy of greater than and equal to (\>=) 6 months
You may not qualify if:
- Histological evidence of transformation of NHL, or types of NHL other than follicular lymphoma
- Presence or history of central nervous system disease
- History of malignancy other than follicular NHL
- Recent major surgery (within 4 weeks prior to screening), excluding lymph node biopsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
Unknown Facility
Buenos Aires, 1425, Argentina
Unknown Facility
Buenos Aires, C1114AAN, Argentina
Unknown Facility
Buenos Aires, C1221ADC, Argentina
Unknown Facility
Córdoba, 5000, Argentina
Unknown Facility
Rosario, 2000, Argentina
Unknown Facility
Kogarah, New South Wales, 2217, Australia
Unknown Facility
Sydney, New South Wales, 2139, Australia
Unknown Facility
Kurralta Park, South Australia, 5037, Australia
Unknown Facility
Fitzroy, Victoria, 3065, Australia
Unknown Facility
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Unknown Facility
Barretos, São Paulo, 14784-400, Brazil
Unknown Facility
São Paulo, São Paulo, 05403-000, Brazil
Unknown Facility
São Paulo, São Paulo, 05652-000, Brazil
Unknown Facility
Calgary, Alberta, T2N 4N2, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Unknown Facility
Halifax, Nova Scotia, B3H 2Y9, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Québec, Quebec, G1J 1Z4, Canada
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Brno, 625 00, Czechia
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Hradec Králové, 500 05, Czechia
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Prague, 128 08, Czechia
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Herlev, 2730, Denmark
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Guayaquil, EC090114, Ecuador
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Quito, 2569, Ecuador
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Helsinki, 00029, Finland
Unknown Facility
Tampere, 33520, Finland
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Turku, 20520, Finland
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Marseille, 13273, France
Unknown Facility
Montpellier, 34295, France
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Reims, 51092, France
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Haifa, 3109601, Israel
Unknown Facility
Jerusalem, 9112001, Israel
Unknown Facility
Petah Tikva, 49100, Israel
Unknown Facility
Ramat Gan, 52662, Israel
Unknown Facility
Bergamo, Lombardy, 24127, Italy
Unknown Facility
Milan, Lombardy, 20162, Italy
Unknown Facility
Turin, Piedmont, 10126, Italy
Unknown Facility
Pisa, Tuscany, 56100, Italy
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Aguascalientes, 20127, Mexico
Unknown Facility
Mexico City, Distrito Federal, 14050, Mexico
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Monterrey, 64460, Mexico
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Oslo, 0379, Norway
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Lima, 11, Peru
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Lima, 34, Peru
Unknown Facility
Warsaw, 02 776, Poland
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Wroclaw, 50-367, Poland
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Moscow, 115478, Russia
Unknown Facility
Bratislava, 833 10, Slovakia
Unknown Facility
Seoul, 135-710, South Korea
Unknown Facility
Barcelona, Barcelona, 08003, Spain
Unknown Facility
Barcelona, Barcelona, 08036, Spain
Unknown Facility
Salamanca, Salamanca, 37007, Spain
Unknown Facility
Seville, Sevilla, 41013, Spain
Unknown Facility
Huddinge, 14186, Sweden
Unknown Facility
Sundsvall, 85186, Sweden
Unknown Facility
Umeå, 90185, Sweden
Unknown Facility
Uppsala, 75185, Sweden
Unknown Facility
Basel, 4031, Switzerland
Unknown Facility
Cambridge, CB2 0QQ, United Kingdom
Unknown Facility
London, EC1A 7BE, United Kingdom
Unknown Facility
Manchester, M20 4QL, United Kingdom
Unknown Facility
Nottingham, NG5 1PB, United Kingdom
Related Publications (2)
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.
PMID: 24821885DERIVEDMao 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.
PMID: 24265828DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2009
First Posted
June 30, 2009
Study Start
September 1, 2009
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
November 2, 2016
Record last verified: 2016-11