Study of CT-P10 in patients with Low Tumour Burden Follicular Lymphoma
Research type
Research Study
Full title
A Phase 3, Randomised, Parallel-Group, Active-Controlled, Double-Blind Study to Compare Efficacy and Safety between CT P10 and Rituxan in Patients with Low Tumour Burden Follicular Lymphoma
IRAS ID
183058
Contact name
Tobias Menne
Contact email
Sponsor organisation
CELLTRION, Inc.
Eudract number
2014-005324-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 1 months, 30 days
Research summary
Non-Hodgkin Lymphoma is a B-cell malignancy of which there are 3 classes - indolent (low-grade), aggressive (intermediate-grade), and very aggressive (high-grade). Low-grade NHLs are united by the patient’s inability to achieve a long-term cure with conventional treatments. One type of indolent lymphoma is Low Tumour Burden Follicular Lymphoma (LTBFL). The majority of patients have advanced disease and 50% have bone marrow involvement at diagnosis.
Rituximab (a monoclonal antibody) is a highly active and well tolerated first-line single-agent therapy for LTBFL. Rituximab has been shown to delay the need for chemotherapy, lower disease progression and have a significant improvement in overall response rate in patients with previously untreated LTBFL.
The drug that will be tested in this study is called CT-P10, a biosimilar candidate of Rituximab. A “biosimilar” is a drug that is similar but not identical to an approved drug. CT-P10 is considered similar to Rituximab in terms of efficacy and safety.
The purpose of this study is to demonstrate that CT-P10 works as effectively and safely as that of rituximab in patients with untreated low tumour burden follicular lymphoma. Approximately 118 patients will take part in this study with about 59 prescribed CT-P10 and about 59 prescribed rituximab.
Participants will receive either CT P10 or rituximab by an IV infusion weekly for 4 weeks in the Induction Study Period and every 8 weeks for 2 years in the Maintenance Study Period.
There will be 4 periods in the study:
• Screening Period (up to 6 weeks)
• Induction Study Period (up to 4 weeks)
• Maintenance Study Period (up to 2 years)
• Follow-Up Period (until 3 years from the first drug infusion of the last enrolled patient in this study)
The total participation in the study will last approximately 4-5 years depending on when the last patient is enrolled in this study.
Neither the participant nor the study doctor will know what treatment was assigned.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
15/EE/0352
Date of REC Opinion
17 Dec 2015
REC opinion
Further Information Favourable Opinion