Description:
To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall response rate at 7 months
To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall response rate at 7 months
Completed
Phase 3
Drug | Synonyms | Arms |
---|---|---|
CT-P10 | CT-P10 | |
Rituxan | Rituxan |
Name | Type | Description | Interventions |
---|---|---|---|
CT-P10 | Experimental | CT-P10, intervention 375mg/m2, intravenous, 4 cycles in induction period and additional 12 cycles in maintenance period | |
Rituxan | Active Comparator | 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. |
Inclusion Criteria: - Confirmed diagnosis of low tumour burden, CD20+ follicular lymphoma - Ann Arbor Stage II, III or IV Exclusion Criteria: - Has receive rituximab - Allergies or hypersensitivity to murine, chimeric, human or humanised proteins - Previous treatment for NHL - Any malignancy - Current or recent treatment with any other investigational medicinal product or device - pregnant or lactating
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Overall response rate |
Time Frame: | 7months |
Safety Issue: | |
Description: |
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Celltrion |
June 5, 2017