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:1/12/2019
Start Date:September 30, 2014
End Date:April 19, 2018

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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.


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
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Anaheim, California 92801
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1801 West Romneya Drive
Anaheim, California 92801
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Aurora, Colorado 80012
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4504 Seminole Avenue
Baltimore, Maryland 21229
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Baltimore, Maryland 21229
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Bethesda, Maryland 20817
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Chanute, Kansas 66720
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DeKalb, Illinois 60115
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Denver, Colorado 80218
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Dodge City, Kansas 67801
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El Dorado, Kansas 67042
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Fort Sam Houston, Texas 78234
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3551 Roger Brooke Drive
Fort Sam Houston, Texas 78234
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Fort Worth, Texas 76177
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1510 South Central Avenue
Glendale, California 91204
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Grand Island, Nebraska 68803
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Greenville, North Carolina 27834
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Greenville, North Carolina 27834
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Houston, Texas 77090
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Independence, Kansas 67301
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Kansas City, Missouri 64154
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Kansas City, Missouri 64154
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Kingman, Kansas 67068
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22710 Professional Drive
Kingwood, Texas 77339
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Knoxville, Tennessee 37920
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9280 W. Sunset Road Suite 100
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
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
702.952.1251
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Lee's Summit, Missouri 64064
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Liberal, Kansas 67905
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Lone Tree, Colorado 80124
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Los Angeles, California 90017
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Lynwood, California 90262
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McPherson, Kansas 67460
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Montebello, California 90640
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Newton, Kansas 67114
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Parsons, Kansas 67357
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3676 Parker Boulevard
Pueblo, Colorado 81008
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Santa Ana, California 92705
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Shenandoah, Texas 77384
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Silver Spring, Maryland 20902
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Silver Spring, Maryland 20910
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1500 Forest Glen Road
Silver Spring, Maryland 20910
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9319 Pinecroft Drive
The Woodlands, Texas 77380
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Thomasville, Georgia 31799
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818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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Winfield, Kansas 67156
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