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To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma

NCT02260804

Description:

To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall response rate at 7 months

Related Conditions:
  • Follicular Lymphoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: CT-P10 3.4
  • NCT ID: NCT02260804

Conditions

  • Follicular Lymphoma

Interventions

DrugSynonymsArms
CT-P10CT-P10
RituxanRituxan

Purpose

To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall response rate at 7 months

Trial Arms

NameTypeDescriptionInterventions
CT-P10ExperimentalCT-P10, intervention 375mg/m2, intravenous, 4 cycles in induction period and additional 12 cycles in maintenance period
    RituxanActive ComparatorRituxan, 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.

      Eligibility 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
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Overall response rate
      Time Frame:7months
      Safety Issue:
      Description:

      Details

      Phase:Phase 3
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Celltrion

      Last Updated

      June 5, 2017