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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)

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02213263
First received: August 7, 2014
Last updated: September 11, 2017
Last verified: September 2017
  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.

Condition Intervention Phase
Follicular Lymphoma Biological: PF-05280586 Biological: MabThera® Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Objective Response Rate (ORR) according to the revised response criteria for malignant lymphoma [ Time Frame: Week 26 ]

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

Estimated Enrollment: 394
Actual Study Start Date: September 30, 2014
Estimated Study Completion Date: April 25, 2018
Estimated Primary Completion Date: October 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-05280586 Biological: PF-05280586
PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
Active Comparator: MabThera® Biological: MabThera®
MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02213263

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Show 466 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02213263     History of Changes
Other Study ID Numbers: B3281006
2014-000132-41 ( EudraCT Number )
REFLECTIONS ( Other Identifier: Alias Study Number )
Study First Received: August 7, 2014
Last Updated: September 11, 2017

Keywords provided by Pfizer:
rituximab
follicular lymphoma
Non-Hodgkin lymphoma
Non-Hodgkin's lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 21, 2017