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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)

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pacific Cancer Medical Center, Inc.
Anaheim, California, 92801 United States
Contact
1-800-718-1021
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

NCT02213263
Pfizer
Completed
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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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)
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Follicular Lymphoma
  • 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
  • Experimental: PF-05280586
    Intervention: Biological: PF-05280586
  • Active Comparator: MabThera®
    Intervention: Biological: MabThera®
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
394
April 25, 2018
October 23, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
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
 
 
NCT02213263
B3281006
2014-000132-41 ( EudraCT Number )
REFLECTIONS ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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