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A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)

NCT02213263

Description:

This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall Response Rate, is similar to that of rituximab-EU.

Related Conditions:
  • Follicular Lymphoma
Recruiting Status:

Completed

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)
  • Official Title: A Phase 3, Randomized, Double-blind Study Of Pf-05280586 Versus Rituximab For The First-line Treatment Of Patients With Cd20-positive, Low Tumor Burden, Follicular Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: B3281006
  • SECONDARY ID: 2014-000132-41
  • SECONDARY ID: REFLECTIONS
  • NCT ID: NCT02213263

Conditions

  • Follicular Lymphoma

Interventions

DrugSynonymsArms

Purpose

This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall Response Rate, is similar to that of rituximab-EU.

Detailed Description

Trial Arms

NameTypeDescriptionInterventions
PF-05280586Experimental
    MabThera®Active Comparator

      Eligibility Criteria

      Inclusion Criteria:

      - Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma

      - Ann Arbor Stage II, III, or IV

      Exclusion Criteria:

      - Not a candidate for treatment with rituximab as a single-agent

      - Evidence of transformation to a high grade or diffuse large B-cell lymphoma

      - Any previous systemic therapy for B-cell NHL, including chemotherapy, immunotherapy, or steroids

      - Any prior treatment with rituximab

      - Active, uncontrolled infection

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

      Primary Outcome Measures

      Measure:Objective Response Rate (ORR) according to the revised response criteria for malignant lymphoma
      Time Frame:Week 26
      Safety Issue:
      Description:

      Secondary Outcome Measures

      Measure:Time to Treatment Failure (TTF)
      Time Frame:Week 52
      Safety Issue:
      Description:
      Measure:Progression-Free Survival (PFS)
      Time Frame:Week 52
      Safety Issue:
      Description:
      Measure:Complete Remission (CR) rate
      Time Frame:Week 26
      Safety Issue:
      Description:
      Measure:Duration of response
      Time Frame:Week 52
      Safety Issue:
      Description:
      Measure:Overall survival
      Time Frame:Week 52
      Safety Issue:
      Description:
      Measure:Maximum observed plasma concentration (Cmax)
      Time Frame:Week 52
      Safety Issue:
      Description:
      Measure:Minimum observed plasma concentration (Cmin)
      Time Frame:Week 52
      Safety Issue:
      Description:
      Measure:CD19-positive B-cell counts
      Time Frame:Week 52
      Safety Issue:
      Description:
      Measure:Incidence of anti-drug antibodies (ADA) and safety associated with immune response
      Time Frame:Week 52
      Safety Issue:
      Description:

      Details

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

      Trial Keywords

      • rituximab
      • follicular lymphoma
      • Non-Hodgkin lymphoma
      • Non-Hodgkin's lymphoma

      Last Updated

      March 14, 2017