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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)

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ClinicalTrials.gov Identifier: NCT02213263
Recruitment Status : Active, not recruiting
First Posted : August 11, 2014
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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 : 395 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
Primary Completion Date : October 23, 2017
Estimated Study Completion Date : April 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

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

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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

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 ClinicalTrials.gov identifier (NCT number): NCT02213263


  Show 438 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

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 )
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

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