Status:
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)
Lead Sponsor:
Pfizer
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 thi...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma
- Ann Arbor Stage II, III, or IV
Exclusion
- 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
Key Trial Info
Start Date :
September 30 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2018
Estimated Enrollment :
394 Patients enrolled
Trial Details
Trial ID
NCT02213263
Start Date
September 30 2014
End Date
April 19 2018
Last Update
June 20 2019
Active Locations (423)
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1
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
2
The Oncology Institute of Hope and Innovation
Anaheim, California, United States, 92801
3
Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.
Corona, California, United States, 92879
4
The Oncology Institute of Hope and Innovation
Downey, California, United States, 90241