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

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Trial Summary
Trial Overview
Inclusion Criteria

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
We found this trial at
91
sites
Pacific Cancer Medical Center
Anaheim, California 92801
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The Oncology Institute of Hope and Innovation
1801 West Romneya Drive
Anaheim, California 92801
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Rocky Mountain Cancer Centers
Aurora, Colorado 80012
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Aurora, CO
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PET/CT facility Seton Imaging Center
4504 Seminole Avenue
Baltimore, Maryland 21229
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Baltimore, MD
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Saint Agnes Hospital
Baltimore, Maryland 21229
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Baltimore, MD
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Rcca Md, Llc
Bethesda, Maryland 20817
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Bethesda, MD
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Rocky Mountain Cancer Centers, Site #191
Boulder, Colorado 80303
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Boulder, CO
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Cancer Center of Kansas
Chanute, Kansas 66720
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Chanute, KS
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Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc.
Corona, California 92879
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Corona, CA
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Northwestern Medicine West Region
DeKalb, Illinois 60115
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DeKalb, IL
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Rocky Mountain Cancer Centers
Denver, Colorado 80218
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Denver, CO
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Cancer Center of Kansas
Dodge City, Kansas 67801
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Dodge City, KS
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The Oncology Institute of Hope and Innovation
Downey, California 90241
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Downey, CA
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Cancer Center of Kansas
El Dorado, Kansas 67042
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El Dorado, KS
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Willamette Valley Cancer Institute/Research Ctr
Eugene, Oregon 97401
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Eugene, OR
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San Antonio Military Medical Center
Fort Sam Houston, Texas 78234
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Fort Sam Houston, TX
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San Antonio Military Medical Center- Department of Radiology
Fort Sam Houston, Texas 78234
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Fort Sam Houston, TX
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San Antonio Military Medical Center- Department of Pharmacy
3551 Roger Brooke Drive
Fort Sam Houston, Texas 78234
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Fort Sam Houston, TX
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Investigational Products Center (IPC)
Fort Worth, Texas 76177
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Fort Worth, TX
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Investigational Products Center (IPC)
Fort Worth, Texas 76177
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Fort Worth, TX
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Investigational Products Center (I PC)
Fort Worth, Texas 76177
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Fort Worth, TX
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Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, California 92708
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Fountain Valley, CA
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Cancer Center,Northwestern Medicine, West Region
Geneva, Illinois 60134
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Geneva, IL
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Global Cancer Research Institute (GCRI), Inc.
Gilroy, California 95020
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Gilroy, CA
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Saint Louise Regional Hospital Radiology Department (Radiology Only)
Gilroy, California 95020
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Gilroy, CA
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South Valley Imaging Center (Imaging Only)
Gilroy, California 95020
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Gilroy, CA
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Los Angeles Hematology Oncology Medical Group
Glendale, California 91206
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Glendale, CA
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Los Angeles Hematology Oncology Medical Group
Glendale, California 91206
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Glendale, CA
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The Oncology Institute of Hope and Innovation
1510 South Central Avenue
Glendale, California 91204
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Glendale, CA
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Saint Francis Medical Center, Saint Francis Cancer Treatment Center
Grand Island, Nebraska 68803
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Grand Island, NE
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Saint Francis Medical Center
Grand Island, Nebraska 68803
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Grand Island, NE
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Vidant Medical Center
Greenville, North Carolina 27834
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Greenville, NC
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Vidant Medical Center Pharmacy
Greenville, North Carolina 27834
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Greenville, NC
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Brody School of Medicine at East Carolina University
Greenville, North Carolina 27834
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Greenville, NC
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Saint Francis Medical Center, Saint Francis Cancer Treatment Center
Hastings, Nebraska 68901
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Hastings, NE
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Comprehensive Cancer Centers of Nevada
Henderson, Nevada
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Henderson, NV
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Comprehensive Cancer Centers of Nevada
Henderson, Nevada
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Millennium Oncology
Houston, Texas 77090
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Houston, TX
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Cancer Center of Kansas
Independence, Kansas 67301
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Independence, KS
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US Oncology Investigational Products Center (IPC)
Irving, Texas 75063
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Irving, TX
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The University of Kansas Cancer Center
Kansas City, Missouri 64154
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Kansas City, MO
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The University of Kansas Cancer Center
Kansas City, Missouri 64154
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Cancer Center of Kansas
Kingman, Kansas 67068
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Kingman, KS
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Millennium Oncology
22710 Professional Drive
Kingwood, Texas 77339
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Kingwood, TX
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University of Tennessee Medical Center
Knoxville, Tennessee 37920
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Rocky Mountain Cancer Centers (RMCC) - Lakewood -St Anthony
Lakewood, Colorado 80228
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Lakewood, CO
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Rocky Mountain Cancer Center-Lakewood (Laboratory)
Lakewood, Colorado 80228
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Comprehensive Cancer Centers of Nevada
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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Comprehensive Cancer Centers of Nevada
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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Comprehensive Cancer Centers of Nevada
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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The University of Kansas Cancer Center
Lee's Summit, Missouri 64064
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Lee's Summit, MO
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Cancer Center of Kansas
Liberal, Kansas 67905
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Liberal, KS
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Krankenhaus der Barmherzigen Schwestern Linz
Linz,
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Linz,
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Rocky Mountain Cancer Centers
Lone Tree, Colorado 80124
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Lone Tree, CO
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Oncology Institute of Hope and Innovation
Long Beach, California
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Long Beach, CA
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Texas Oncology-Longview Cancer Center
Longview, Texas 75601
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Longview, TX
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Los Angeles Hematology/Oncology Medical Group
Los Angeles, California 90017
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Los Angeles, CA
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Oncology Institute of Hope and Innovation
Lynwood, California 90262
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Lynwood, CA
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Toledo Clinic Cancer Center - Maumee
Maumee, Ohio 43537
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Maumee, OH
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Cancer Center of Kansas
McPherson, Kansas 67460
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McPherson, KS
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The Oncology Institute of Hope and Innovation
Montebello, California 90640
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Montebello, CA
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Cancer Center of Kansas
Newton, Kansas 67114
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Newton, KS
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The University of Kansas Cancer Center
Overland Park, Kansas 66210
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Overland Park, KS
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Comprehensive Cancer Center At Desert Regional Medical Center
Palm Springs, California 92262
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Palm Springs, CA
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Cancer Center of Kansas
Parsons, Kansas 67357
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Parsons, KS
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Rocky Mountain Cancer Center Pueblo
3676 Parker Boulevard
Pueblo, Colorado 81008
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Pueblo, CO
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Torrance Health Association Dba Torrance Memorial Physician Network/Cancer Care Associates
Redondo Beach, California 90277
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Redondo Beach, CA
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Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc.
Riverside, California 92501
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Riverside, CA
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Cancer Center of Kansas
Salina, Kansas 67401
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Salina, KS
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Global Cancer Research Institute
San Jose, California 95124
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San Jose, CA
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OConnor Hospital
San Jose, California 95128
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San Jose, CA
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PET Imaging of San Jose (Imaging Only)
San Jose, California 95128
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San Jose, CA
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The Oncology Institute of Hope and Innovation
Santa Ana, California 92705
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Santa Ana, CA
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Millennium Oncology
Shenandoah, Texas 77384
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Shenandoah, TX
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Holy Cross Hospital Resource Center
Silver Spring, Maryland 20902
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Silver Spring, MD
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Holy Cross Hospital
Silver Spring, Maryland 20910
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Silver Spring, MD
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Holy Cross Hospital, Hospital Pharmacy
1500 Forest Glen Road
Silver Spring, Maryland 20910
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Millennium Oncology
9319 Pinecroft Drive
The Woodlands, Texas 77380
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The Woodlands, TX
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John D. Archbold Memorial Hospital
Thomasville, Georgia 31799
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Thomasville, GA
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Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
Thomasville, Georgia 31792
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Toledo Clinic Cancer Center-Toledo
Toledo, Ohio 43623
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Toledo, OH
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Toledo Clinic Inc.
Toledo, Ohio 43623
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Torrance Memorial Medical Center
Torrance, California 90505
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Texas Oncology-Tyler
Tyler, Texas 75702
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Tyler, TX
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Cancer Center of Kansas
Wellington, Kansas 67152
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Wellington, KS
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Maryland Oncology Hematology, P.A.
Wheaton, Maryland 20902
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Wheaton, MD
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The Oncology Institute of Hope and Innovation
Whittier, California 90606
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Whittier, CA
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Innovative Clinical Research Institute (ICRI)
Whittier, California 90603
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Whittier, CA
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Cancer Center of Kansas
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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Cancer Center of Kansas
Winfield, Kansas 67156
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Winfield, KS
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Yakima Valley Memorial Hospital North Star Lodge Cancer Center
Yakima, Washington 98902
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Yakima, WA
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