CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 258 enrolled
Drug / intervention
CT-P10 +1 morebiological
Likely dose
CT-P10 375mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02260804
NCT02260804Phase 3Completed

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

Celltrion·interventional·Posted Oct 9, 2014·Updated Apr 8, 2021

In Brief

A Phase 3 clinical trial evaluating CT-P10 and Rituxan for Follicular Lymphoma. Completed, enrolled 258 participants across 1 site.

Detailed Summary

To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall response rate at 7 months

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 9, 2014
Enrollment StartNov 9, 2015
Primary CompletionJan 4, 2018
Study CompletionSep 4, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.7 years ago

Interventions

CT-P10biological

375mg/m2, IV on day1 of 4 cycles in induction period, and 12 cycles in maintenance period.

Rituxanbiological

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.