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)
Status: | Completed |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/30/2019 |
Start Date: | September 30, 2014 |
End Date: | April 19, 2018 |
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.
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.
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
We found this trial at
91
sites
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Corona, California 92879
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3551 Roger Brooke Drive
Fort Sam Houston, Texas 78234
Fort Sam Houston, Texas 78234
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Fountain Valley, California 92708
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9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Redondo Beach, California 90277
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Riverside, California 92501
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Thomasville, Georgia 31792
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Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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