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

Last updated date
Study Location
Pacific Cancer Medical Center, Inc.
Anaheim, California, 92801, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Follicular Lymphoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- Ann Arbor Stage II, III, or IV

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Follicular LymphomaA 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
  1. Anaheim, California
  2. Anaheim, California
  3. Corona, California
  4. Downey, California
  5. Fountain Valley, California
  6. Gilroy, California
  7. Gilroy, California
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  418. Cheltenham, Glos.
  419. Bath,
  420. London,
  421. Newcastle upon Tyne,
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  423. Sunderland,
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Follicular LymphomaStudy Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL)
NCT00562965
  1. Mission Hills, California
  2. Evansville, Indiana
  3. Baltimore, Maryland
  4. Novi, Michigan
  5. Southfield, Michigan
  6. Saint Louis Park, Minnesota
  7. Columbus, Mississippi
  8. Corinth, Mississippi
  9. Tupelo, Mississippi
  10. Hackensack, New Jersey
  11. Hackensack, New Jersey
  12. Morristown, New Jersey
  13. Armonk, New York
  14. Bronx, New York
  15. New Rochelle, New York
  16. Pomona, New York
  17. Wenatchee, Washington
  18. Rosario, Santa FE
  19. Gent,
  20. Wilrijk,
  21. Greenfield Park, Quebec
  22. Montreal, Quebec
  23. Sherbrooke, Quebec
  24. Quebec,
  25. Shatin, NEW Territories
  26. Hong Kong,
  27. Pune, Maharashtra
  28. Pune, Maharashtra
  29. Kolkata, WEST Bengal
  30. Pavia,
  31. Seoul,
  32. Monterrey, Nuevo LEON
  33. Warszawa,
  34. Coimbra,
  35. Moscow,
  36. Johannesburg, Gauteng
  37. Majadahonda, Madrid
  38. Barcelona,
  39. Madrid,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Follicular Lymphoma
Intervention  ICMJE
  • 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
  • Biological: MabThera®
    MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
Study Arms  ICMJE
  • Experimental: PF-05280586
    Intervention: Biological: PF-05280586
  • Active Comparator: MabThera®
    Intervention: Biological: MabThera®
Publications * Sharman JP, Liberati AM, Ishizawa K, Khan T, Robbins J, Alcasid A, Rosenberg JA, Aurer I. A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera(®)) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL). BioDrugs. 2020 Apr;34(2):171-181. doi: 10.1007/s40259-019-00398-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2014)
394
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 19, 2018
Actual Primary Completion Date October 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belarus,   Belgium,   Brazil,   Croatia,   France,   Georgia,   Germany,   Greece,   India,   Italy,   Japan,   Korea, Republic of,   Lebanon,   Mexico,   Peru,   Philippines,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   South Africa,   Spain,   Switzerland,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02213263
Other Study ID Numbers  ICMJE B3281006
2014-000132-41 ( EudraCT Number )
REFLECTIONS ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP