A study to Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma
Phase 3
- Conditions
- Health Condition 1: C822- Follicular lymphoma grade III, unspecifiedHealth Condition 2: null- Low Tumour Burden Follicular Lymphoma
- Registration Number
- CTRI/2016/01/006493
- Lead Sponsor
- CELLTRION Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Key brief inclusion criteria:
•Confirmed diagnosis of low tumour burden, CD20+ follicular lymphoma grade 1 to 3a according to the World Health Organization 2008 classification
•Ann Arbor Stage II, III or IV
Exclusion Criteria
Key brief exclusion criteria:
•Has received rituximab
•Allergies or hypersensitivity to murine, chimeric, human or humanised proteins
•Previous treatment for NHL
•Any malignancy, patient has known central nervous system involvement or any evidence of spinal cord compression by lymphoma
•Current or recent treatment with any other investigational medicinal product or device
•pregnant or lactating
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Objective: <br/ ><br>To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall <br/ ><br>response rate (CR + CRu + PR) at 7 months (Prior to Cycle 3 of the Maintenance Study Period) <br/ ><br>according to the Modified Response Criteria for Malignant Lymphoma.Timepoint: At 7 months (Prior to Cycle 3 of the Maintenance Study Period) according to the Modified Response Criteria for Malignant Lymphoma.
- Secondary Outcome Measures
Name Time Method The secondary objectives are to assess additional efficacy parameters, pharmacokinetics, pharmacodynamics, overall safety, and biomarkers of CT-P10 incomparison with Rituxan.Timepoint: 1. Overall response rate during the study period <br/ ><br>â?¢ Progression-free survival, or death from any cause, whichever occurs first <br/ ><br>â?¢ Time to progressionor death as a result of lymphoma, whichever occurs first <br/ ><br>â?¢ Overall survival