A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients

Last updated: June 19, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Lymphoma

Follicular Lymphoma

Treatment

AZD0486

R-CVP

Surovatamig

Clinical Study ID

NCT06549595
D7401C00001
2023-510098-33-00
  • Ages 18-130
  • All Genders

Study Summary

This is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the Surovatamig (AZD0486) plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant must be at least 18 years of age, inclusive, at the time of signing theICF.

  2. Histologically confirmed diagnosis of classic FL per WHO 2022 classification

  3. ECOG performance status of 0 to 2

  4. No prior systemic lymphoma-directed therapy

  5. Need for systemic treatment meeting at least 1 GELF criteria

  6. FDG-avid and measurable disease

  7. Stage II to IV and FLIPI 2-5 [Phase III only]

  8. Adequate liver, hematological, renal and cardiac function.

The above is a summary, other inclusion criteria details may apply

Exclusion

Exclusion Criteria:

  1. Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicularlymphoma Grade 3B (WHO 2016 classification) or suspicion for histologictransformation to high-grade/aggressive lymphoma

  2. Contra-indication to BR, RCVP, and R-CHOP

  3. Participants with or history of CNS lymphoma

  4. History of a clinically relevant CNS medical condition or pathology that requiredtreatment in the preceding year, is currently symptomatic or that which the treatinginvestigator considers to have the potential to interfere with the evaluation ofsafety

  5. Presence of >5000 circulating lymphoma cells

  6. Active or uncontrolled infection (including EBV) requiring systemic therapy andwhich places participant at unacceptable risk if he/she were to participate in thestudy. If a participant has a history of COVID-19 within 1 month of C1D1 orcontracts COVID while on study treatment, participant must have 2 consecutivenegative tests (PCR testing is preferable) performed at least 48 hours apart priorto resuming dosing. All symptoms related to COVID-19 infection should have fullyresolved before initiating or resuming treatment

  7. Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)

The above is a summary, other exclusion criteria details may apply

Study Design

Total Participants: 1018
Treatment Group(s): 5
Primary Treatment: AZD0486
Phase: 3
Study Start date:
August 07, 2024
Estimated Completion Date:
November 26, 2031

Study Description

The study consists of 2 sequential parts.

  1. Safety Run-in - this part will compare dose levels of Surovatamig (AZD0486) in combination with rituximab in order to establish the RP3D.

  2. Phase III - The Phase III part will assess the superiority of Surovatamig (AZD0486) at RP3D in combination with rituximab, compared to Investigator's choice between 3 standard chemoimmunotherapy regimens. Phase 3 consists of 3 arms

    1. Arm A: treatment with Surovatamig plus rituximab Schedule A

    2. Arm B: treatment with Surovatamig plus rituximab Schedule B

    3. Arm C (Comparator arm): one of the following standard regimens per Investigator's choice: R-CVP + rituximab maintenance, R-CHOP + rituximab maintenance or B-R + rituximab maintenance

Connect with a study center

  • Research Site

    Clayton, 3168
    Australia

    Site Not Available

  • Research Site

    Darlinghurst, 2010
    Australia

    Site Not Available

  • Research Site

    Garran, 2605
    Australia

    Active - Recruiting

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    Heidelberg, 3084
    Australia

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    Macquarie University, 2109
    Australia

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    Nedlands, 6009
    Australia

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    Brussels, 1090
    Belgium

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    Brussels 2800866, 1090
    Belgium

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    Ghent, 9000
    Belgium

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    Mechelen, 2800
    Belgium

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    Porto Alegre, 90035-003
    Brazil

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    São Paulo, 04501-000
    Brazil

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    São Paulo 3448439, 05652-900
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    Winnipeg, Manitoba R3E 0V9
    Canada

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    Halifax, Nova Scotia B3H 2Y9
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    Barrie, Ontario L4M 6M2
    Canada

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    Hamilton, Ontario L8V 5C2
    Canada

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    Oshawa, Ontario L1G 2B9
    Canada

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    Toronto, Ontario M5G 1X6
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    Chicoutimi, Quebec G7H 5H6
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    Montreal, Quebec H4J 1C5
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    Québec, Quebec G1J 1Z4
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    Saint-Jérôme, Quebec J7Z 2V4
    Canada

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    Québec 6325494, Quebec 6115047 G1V 4G2
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    Beijing, 100730
    China

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    Beijing 1816670, 100730
    China

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    Changchun, 130021
    China

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    Changsha, 410013
    China

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    Chengdu, 610078
    China

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    Chongqing, 400030
    China

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    Fuzhou, 350001
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    Guangzhou, 510060
    China

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    Guangzhou 1809858, 510060
    China

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    Hangzhou, 310003
    China

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    Hangzhou 1808926, 310003
    China

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    Harbin, 150081
    China

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    Hefei, 230031
    China

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    Lanzhou, 730000
    China

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    Nanchang, 330029
    China

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    Nanchang 1800163, 330006
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    Nanjing, 210029
    China

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    Nanning, 530021
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    Shandong, 250117
    China

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    Shanghai, 200065
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    Shanghai 1796236, 20032
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    Shenyang, 110001
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    Shenyang 2034937, 110001
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    Shijiazhuang, 054001
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    Suzhou, 215006
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    Tianjin, 300020
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    Wenzhou, 325000
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    Wuhan, 430079
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    Xi'an, 710061
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    Xiamen, 361003
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    Zhengzhou, 450008
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    Zhengzhou 1784658, 450008
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    Brno, 625 00
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    Hradec Králové, 500 05
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    Prague, 12808
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    Aalborg, 9100
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    Copenhagen, 2100
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    Odense C, 5000
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    Roskilde, 4000
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    Helsinki, 00029
    Finland

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    Kuopio, 70029
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    Tampere, 33520
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    Berlin, 13353
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    Deggendorf, 94469
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    Düsseldorf, 40479
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    Göttingen, 37075
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    Minatoku, 105-8470
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    Osaka, 541-8567
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    Sapporo, 003-0006
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    Sapporo 2128295, 060-8638
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    Toyoake-shi, 470-1192
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    Yamagata, 990-9585
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    Yokohama, 241-8515
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    Seoul, 05505
    Korea, Republic of

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    Gliwice, 44-102
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    Katowice, 40-519
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    Krakow, 30-727
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    Lublin, 20-090
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    Wroclaw, 53-439
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    San Juan, 00918
    Puerto Rico

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    Busan, 49241
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    Busan 1838524, 49201
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    Goyang-si, 10408
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    Jeonnam, 519-763
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    Seoul 1835848, 05505
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    Barcelona 3128760, 08035
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    El Palmar, 30120
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    Las Palmas de Gran Canaria, 35020
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    Madrid, 28041
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    Madrid 3117735, 28040
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    Oviedo, 33011
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    Pamplona, 31008
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    Falun, 79182
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    Uppsala, 75185
    Sweden

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    Changhua, 50006
    Taiwan

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    Kaohsiung, 833
    Taiwan

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    Kaohsiung City, 833
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    Kaohsiung City 1673820, 833
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    Lukang Township, 505029
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    Tainan, 704
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    Taipei, 106
    Taiwan

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    Bangkok, 10700
    Thailand

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    Bangkok 1609350, 10330
    Thailand

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    Chiang Mai, 50200
    Thailand

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    Khon Kaen, 40002
    Thailand

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    Ankara, 6200
    Turkey

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    Ankara, 06620
    Turkey (Türkiye)

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    Ankara 323786, 6200
    Turkey (Türkiye)

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    London, EC1M6BQ
    United Kingdom

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    London 2643743, EC1M6BQ
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    Newcastle upon Tyne, NE7 7DN
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    Norwich, NR4 7UY
    United Kingdom

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    Nottingham, NG5 1PB
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    Plymouth, PL6 8DH
    United Kingdom

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    Southampton, SO16 6YD
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    Huntsville, Alabama 35805
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    Anchorage, Alaska 99508
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    Phoenix, Arizona 85054
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    Clovis, California 93611
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    Los Alamitos, California 90720
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    San Diego, California 92121
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    Santa Monica, California 90404
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    Aurora, Colorado 80045
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    New Haven, Connecticut 06510
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    Newark, Delaware 19713
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    Jacksonville, Florida 32224
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    Atlanta, Georgia 30322
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    Macon, Georgia 31201
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    Evanston, Illinois 60201
    United States

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    Peoria, Illinois 61615
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    Fort Wayne, Indiana 46804
    United States

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    Des Moines, Iowa 50309
    United States

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    Iowa City, Iowa 52242
    United States

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    Lexington, Kentucky 40536
    United States

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    Louisville, Kentucky 40207
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    Baton Rouge, Louisiana 70808
    United States

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    Baltimore, Maryland 21201
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    Bethesda, Maryland 20817
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    Columbia, Maryland 21044
    United States

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    Boston, Massachusetts 02215
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    Ann Arbor, Michigan 48109
    United States

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    Detroit, Michigan 48201
    United States

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    Ypsilanti, Michigan 48197
    United States

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    Saint Paul, Minnesota 55102
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    Springfield, Missouri 65807
    United States

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    Hackensack, New Jersey 07601
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    New Brunswick, New Jersey 08901
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    Albany, New York 12206
    United States

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    New Hyde Park, New York 11042
    United States

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    New York, New York 10065
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    New York 5128581, New York 5128638 10032
    United States

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    Charlotte, North Carolina 28204
    United States

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    Winston-Salem, North Carolina 27103
    United States

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    Blue Ash, Ohio 45242
    United States

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    Columbus, Ohio 43210
    United States

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    Eugene, Oregon 97401
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    Pittsburgh, Pennsylvania 15232
    United States

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    Nashville, Tennessee 37203
    United States

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    Austin, Texas 78705
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    Shenandoah, Texas 77380
    United States

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    Tyler, Texas 75702
    United States

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    Salt Lake City, Utah 84112
    United States

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    Fairfax, Virginia 22031
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    Richmond, Virginia 23219
    United States

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    Tacoma, Washington 98405
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    Madison, Wisconsin 53792
    United States

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    Milwaukee, Wisconsin 53226
    United States

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