To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma
Conditions
Follicular Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Follicular
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: CT-P10 Type: Biological
Name: Rituxan Type: Biological
Overall Status
Not yet recruiting
Summary
To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall response rate at 7 months
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Start Date
October 2015
Completion Date
August 2020
Sponsors
Celltrion
Source
Celltrion
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page