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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02213263
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : June 12, 2018
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Follicular Lymphoma Biological: PF-05280586 Biological: MabThera® Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 394 participants
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
Actual Study Start Date : September 30, 2014
Actual Primary Completion Date : October 23, 2017
Actual Study Completion Date : April 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02213263

  Show 439 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT02213263     History of Changes
Other Study ID Numbers: B3281006
2014-000132-41 ( EudraCT Number )
REFLECTIONS ( Other Identifier: Alias Study Number )
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

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

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