Trials / Completed
CompletedNCT02162771
To Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- Celltrion · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Rituxan | |
| BIOLOGICAL | CT-P10 | |
| DRUG | Cyclophosphamide | |
| DRUG | Vincristine | |
| DRUG | Prednisone |
Timeline
- Start date
- 2014-07-14
- Primary completion
- 2016-01-12
- Completion
- 2018-12-29
- First posted
- 2014-06-13
- Last updated
- 2020-01-29
- Results posted
- 2020-01-29
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02162771. Inclusion in this directory is not an endorsement.