To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma
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|ClinicalTrials.gov Identifier: NCT02260804|
Recruitment Status : Active, not recruiting
First Posted : October 9, 2014
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Follicular Lymphoma||Biological: CT-P10 Biological: Rituxan||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||174 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||August 2019|
CT-P10, intervention 375mg/m2, intravenous, 4 cycles in induction period and additional 12 cycles in maintenance period
375mg/m2, IV on day1 of 4 cycles in induction period, and 12 cycles in maintenance period.
Active Comparator: 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.
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.
- Overall response rate [ Time Frame: 7months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02260804
|Korea, Republic of|
|Seoul, Korea, Republic of|
|Study Director:||SungYoung Lee||Celltrion|