Status:
COMPLETED
To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma
Lead Sponsor:
Celltrion
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall response rate at 7 months
Eligibility Criteria
Inclusion
- Confirmed diagnosis of low tumour burden, CD20+ follicular lymphoma
- Ann Arbor Stage II, III or IV
Exclusion
- Has receive rituximab
- 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
Key Trial Info
Start Date :
November 9 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2019
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT02260804
Start Date
November 9 2015
End Date
September 4 2019
Last Update
April 8 2021
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea