Trials / Completed
CompletedNCT02260804
To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 258 (actual)
- Sponsor
- Celltrion · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall response rate at 7 months
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CT-P10 | 375mg/m2, IV on day1 of 4 cycles in induction period, and 12 cycles in maintenance period. |
| BIOLOGICAL | Rituxan | 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. |
Timeline
- Start date
- 2015-11-09
- Primary completion
- 2018-01-04
- Completion
- 2019-09-04
- First posted
- 2014-10-09
- Last updated
- 2021-04-08
- Results posted
- 2021-04-08
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02260804. Inclusion in this directory is not an endorsement.