To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma
NCT ID: NCT02260804
Last Updated: 2021-04-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
258 participants
INTERVENTIONAL
2015-11-09
2019-09-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CT-P10
CT-P10, intervention 375mg/m2, intravenous, 4 cycles in induction period and additional 12 cycles in maintenance period
CT-P10
375mg/m2, IV on day1 of 4 cycles in induction period, and 12 cycles in maintenance period.
Rituxan
Rituxan, 375mg/m2 intravenous, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.
Rituxan
375mg/m2, IV on day1 of 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.
Interventions
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CT-P10
375mg/m2, IV on day1 of 4 cycles in induction period, and 12 cycles in maintenance period.
Rituxan
375mg/m2, IV on day1 of 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.
Eligibility Criteria
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Inclusion Criteria
* Ann Arbor Stage II, III or IV
Exclusion Criteria
* Allergies or hypersensitivity to murine, chimeric, human or humanised proteins
* Previous treatment for NHL
* Any malignancy
* Current or recent treatment with any other investigational medicinal product or device
* pregnant or lactating
18 Years
ALL
No
Sponsors
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Celltrion
INDUSTRY
Responsible Party
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Principal Investigators
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SungHyun Kim
Role: STUDY_DIRECTOR
Celltrion
Locations
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Severance Hospital
Seoul, , South Korea
Countries
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References
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Kwak LW, Sancho JM, Cho SG, Nakazawa H, Suzumiya J, Tumyan G, Kim JS, Menne T, Mariz J, Ilyin N, Jurczak W, Lopez Martinez A, Samoilova O, Zhavrid E, Yanez Ruiz E, Trneny M, Popplewell L, Ogura M, Kim WS, Lee SJ, Kim SH, Ahn KY, Buske C. Efficacy and Safety of CT-P10 Versus Rituximab in Untreated Low-Tumor-Burden Follicular Lymphoma: Final Results of a Randomized Phase III Study. Clin Lymphoma Myeloma Leuk. 2022 Feb;22(2):89-97. doi: 10.1016/j.clml.2021.08.005. Epub 2021 Aug 28.
Ogura M, Sancho JM, Cho SG, Nakazawa H, Suzumiya J, Tumyan G, Kim JS, Lennard A, Mariz J, Ilyin N, Jurczak W, Lopez Martinez A, Samoilova O, Zhavrid E, Yanez Ruiz E, Trneny M, Popplewell L, Coiffier B, Buske C, Kim WS, Lee SJ, Lee SY, Bae YJ, Kwak LW. Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 in comparison with rituximab in patients with previously untreated low-tumour-burden follicular lymphoma: a randomised, double-blind, parallel-group, phase 3 trial. Lancet Haematol. 2018 Nov;5(11):e543-e553. doi: 10.1016/S2352-3026(18)30157-1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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CT-P10 3.4
Identifier Type: -
Identifier Source: org_study_id
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