At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 140 enrolled
Drug / intervention
Rituxan +4 morebiological
Likely dose
Not stated in 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.
A Phase 3, Randomised, Parallel-Group, Active-Controlled, Double-Blind Study to Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan, Each Administered in Combination With Cyclophosphamide, Vincristine, and Prednisone (CVP) in Patients With Advanced Follicular Lymphoma
In Brief
A Phase 3 clinical trial evaluating Rituxan, CT-P10, and 3 other interventions for Lymphoma, Follicular. Completed, enrolled 140 participants.
Detailed Summary
This study is a Phase 3 prospective, randomised, parallel-group, active controlled, double blind, multicentre, international study with 2 coprimary endpoints designed to demonstrate equivalence in pharmacokinetics (Part 1), as well as noninferiority in efficacy (Part 2), of CT-P10 to Rituxan when coadministered with CVP and to assess efficacy and safety in patients with advanced (stage III-IV) FL. Part 1 and Part 2 of the study will run in parallel.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Follicular
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 2014
Enrollment StartJul 2014
Primary CompletionJan 2016
Study CompletionDec 2018
TodayJul 2026
First PostedJun 13, 2014
Enrollment StartJul 14, 2014
Primary CompletionJan 12, 2016
Study CompletionDec 29, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 12.1 years ago
Interventions
Rituxanbiological
CT-P10biological
Cyclophosphamidedrug
Vincristinedrug
Prednisonedrug