A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors

Last updated: May 28, 2026
Sponsor: BeOne Medicines
Overall Status: Active - Recruiting

Phase

3

Condition

Lymphocytic Leukemia, Chronic

Chronic Lymphocytic Leukemia

Platelet Disorders

Treatment

Rituximab

Idelalisib

BGB-16673

Clinical Study ID

NCT06846671
BGB-16673-302
2024-518893-15-00
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (idelalisib plus rituximab [for CLL only] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 internationalworkshop on chronic lymphocytic leukemia (iwCLL) criteria.

  2. Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.

  3. Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI)

  4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2

  5. Adequate liver function

  6. Adequate blood clotting function

Exclusion

Exclusion Criteria:

  1. Known prolymphocytic leukemia or history of, or currently suspected, Richter'stransformation

  2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy inthe last 3 months

  3. Known central nervous system involvement

  4. Prior exposure to any BTK protein degraders

  5. Active fungal, bacterial and/or viral infection requiring parenteral systemictherapy

  6. Clinically significant cardiovascular disease

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 250
Treatment Group(s): 5
Primary Treatment: Rituximab
Phase: 3
Study Start date:
April 10, 2025
Estimated Completion Date:
February 14, 2030

Study Description

Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong life and control disease-related symptoms.

In this study, participants with relapsed/refractory (R/R) CLL who were previously exposed to a BTKi and a BCL2i will receive BGB-16673 or the investigator's choice of idelalisib plus rituximab (for CLL only) or bendamustine plus rituximab or venetoclax plus rituximab retreatment. The main purpose of this study is to compare the length of time that participants live without their CLL or SLL worsening between those participants who receive BGB-16673 versus the investigator's choice of treatment (idelalisib plus rituximab or bendamustine plus rituximab, or venetoclax plus rituximab).

Approximately 250 participants will be included in this study around the world. Participants will be randomly allocated to receive either BGB-16673 or the investigator's choice of treatment.

"Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website."

Connect with a study center

  • Hospital Aleman

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  • FUNDALEU

    Caba, CP1114
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  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma Buenos Aires, 1413
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  • Instituto Alexander Fleming (Iaf)

    Ciudad Autonoma Buenos Aires, 1426
    Argentina

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  • Concord Repatriation General Hospital

    Concord, New South Wales NSW 2139
    Australia

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  • Gosford Hospital

    Gosford, New South Wales NSW 2250
    Australia

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  • Port Macquarie Base Hospital

    Port Macquarie, New South Wales NSW 2444
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  • Darling Downs Hospital and Health Service

    Toowoomba, Queensland 4350
    Australia

    Site Not Available

  • Toowoomba Hospital

    Toowoomba, Queensland QLD 4350
    Australia

    Active - Recruiting

  • Flinders Medical Centre

    Bedford PK, South Australia SA 5042
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria VIC 3004
    Australia

    Active - Recruiting

  • Perth Blood Institute

    West Perth, Western Australia WA 6005
    Australia

    Active - Recruiting

  • CETUS

    Belo Horizonte, 30110-022
    Brazil

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  • Cetus Oncologia Santa Casa de Belo Horizonte

    Belo Horizonte, 30575-859
    Brazil

    Site Not Available

  • Hospital Sirio Libanes Brasilia

    Brasília, 70200-730
    Brazil

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  • Hospital Erasto Gaertner

    Curitiba, 81520-060
    Brazil

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  • Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)

    Florianópolis, 88020-210
    Brazil

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  • Instituto Joinvilense de Hematologia E Oncologia

    Joinville, 89201-260
    Brazil

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  • Complexo Hospitalar de Niteroi

    Niterói, 24020-096
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  • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

    Porto Alegre, 90110-270
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  • Hospital Santa Joana Recife

    Recife, 52011-906
    Brazil

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  • Complexo Hospitalar de Niteroi

    Rio de Janeiro, 24020-096
    Brazil

    Site Not Available

  • Hospital Sao Lucas Dasa Oncologia

    Rio de Janeiro, 22061-080
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  • Oncoclinicas Rio de Janeiro Sa

    Rio de Janeiro, 22250-040
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  • Oncoclinicas Rio de Janeiro Sa

    Rio de Janeiro 3451190, 22250-040
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  • Hospital Sao Rafael (Rede Dor)

    Salvador, 41253-190
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  • Instituto Brasileiro de Controle Do Cancer

    Sao Paulo, 04014-002
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    Sao Paulo, 01401-002
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  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    Sao Paulo, 05653-120
    Brazil

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  • Instituto Brasileiro de Controle Do Cancer

    São Paulo, 04014-002
    Brazil

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  • Instituto Dor de Pesquisa E Ensino Sao Paulo

    São Paulo, 01401-004
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  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652-900
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  • Instituto Brasileiro de Controle Do Cancer

    São Paulo 3448439, 04014-002
    Brazil

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  • Instituto Dor de Pesquisa E Ensino Sao Paulo

    São Paulo 3448439, 04501-000
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  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo 3448439, 05653-120
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  • Hospital Santa Rita de Cassia Afecc

    Vitoria, 29043260
    Brazil

    Site Not Available

  • Hospital Santa Rita de Cassia Afecc

    Vitória, 29043-260
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  • London Health Sciences Centre

    London, Ontario N6A 5W9
    Canada

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  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario K1H 8L6
    Canada

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  • Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre

    Greenfield Park, Quebec J4V 2H1
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  • Jewish General Hospital

    Montreal, Quebec QC H3t 1E2
    Canada

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  • Unite de Recherche Clinique Du Cisss Des Laurentides

    SaintJerome, Quebec J7Z 5T3
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    Site Not Available

  • Fakultni Nemocnice Brno

    Brno, 625 00
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  • Fakultni Nemocnice Hradec Kralove

    Hradec Kralove, 50005
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    Site Not Available

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 500 03
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  • Fakultni Nemocnice Ostrava

    Ostrava, 708 00
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  • Vseobecna Fakultni Nemocnice V Praze

    Prague, 10000
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  • Klinikum Augsburg, Ii Medizinische Klinik

    Augsburg, 86156
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    Site Not Available

  • Universitatsklinikum Augsburg

    Augsburg, 86156
    Germany

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  • Praxis Am Volkspark

    Berlin, 10715
    Germany

    Active - Recruiting

  • Klinikum Chemnitz Ggmbh

    Chemnitz, 09116
    Germany

    Active - Recruiting

  • Universitatsklinikum Essen (Aor)

    Essen, 45122
    Germany

    Active - Recruiting

  • Centrum Fur Haematologie Und Onkologie Bethanien

    Frankfurt am Main, 60389
    Germany

    Active - Recruiting

  • Universitatsklinikum Freiburg I Br Klinik Fur Innere Medizin I

    Freiburg im Breisgau, 79106
    Germany

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  • Universitatsklinikum Hamburg Eppendorf

    Hamburg, 20251
    Germany

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  • Universitatsklinikum Heidelberg

    Heidelberg, 69120
    Germany

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  • Saarland University Medical Center

    Homburg, 66421
    Germany

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  • Invo Institut Fur Versorgungsforschung in Der Onkologie

    Koblenz, 56068
    Germany

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  • Universitaetsklinikum Leipzig Aor

    Leipzig, 04103
    Germany

    Active - Recruiting

  • Universitatsklinikum Munster Medizinische Klinik A

    Münster, 48149
    Germany

    Active - Recruiting

  • Irccs Istituto Tumori Giovanni Paolo Ii

    Bari, 70124
    Italy

    Active - Recruiting

  • Aou Careggi, Servizio Sanitario Toscana

    Florence, 50134
    Italy

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  • Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122
    Italy

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  • Ospedale San Raffaele

    Milan, 20132
    Italy

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  • Ospedale San Raffaele

    Milan 6951411, 20132
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  • Ospedale San Raffaele

    Milano, 20132
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Federico Ii

    Naples, 80131
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  • Aou Maggiore Della Carita

    Novara, 28100
    Italy

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  • Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi

    Pavia, 27100
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  • Ospedale Santa Maria Della Misericordia

    Perugia, 6129
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    Site Not Available

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    Japan

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  • Aiiku Hospital

    Sapporo, Hokkaido 064-0804
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  • Hyogo Prefectural Amagasaki General Medical Center

    AmagasakiCity, Hyōgo 660-8550
    Japan

    Active - Recruiting

  • Kagoshima University Hospital

    Kagoshima, Kagoshima-ken 890-8520
    Japan

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  • University Hospital, Kyoto Prefectural Univ of Medicine

    KyotoShi, Kyoto 602-8566
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai, Miyagi 980-8574
    Japan

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  • Niigata University Medical and Dental Hospital

    Niigata, Niigata 951-8520
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  • Kurashiki Central Hospital

    Kurashikishi, Okayama-ken 710-8602
    Japan

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  • Kansai Medical University Hospital

    Hirakata, Osaka 573-1191
    Japan

    Active - Recruiting

  • Kindai University Hospital

    Sakai, Osaka 590-0197
    Japan

    Active - Recruiting

  • Saitama Medical Center

    Kawagoeshi, Saitama 350-8550
    Japan

    Active - Recruiting

  • Ntt Medical Center Tokyo

    Shinagawaku, Tokyo 141-0022
    Japan

    Active - Recruiting

  • Kumamoto University Hospital

    Kumamoto, 860-8556
    Japan

    Active - Recruiting

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192
    Japan

    Active - Recruiting

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586
    Japan

    Active - Recruiting

  • National Cancer Center (Korea)

    IlsandongGu GoyangSi, Gyeonggi-do 10408
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    HwasunGun, Jeollanam-do 58128
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul St Marys Hospital

    SeochoGu, Seoul Teugbyeolsi 06591
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul St Marys Hospital

    Seoul, Seoul Teugbyeolsi 06591
    Korea, Republic of

    Site Not Available

  • Amsterdam Umc Vu Mc

    Amsterdam, 1081 HV
    Netherlands

    Active - Recruiting

  • Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny

    Brzozów, 36-200
    Poland

    Active - Recruiting

  • Pratia Onkologia Katowice

    Katowice, 40-519
    Poland

    Active - Recruiting

  • Pratia McM Krakow

    Krakow, 30-727
    Poland

    Active - Recruiting

  • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

    Lodz, 93-513
    Poland

    Active - Recruiting

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

    Lodz, 93-513
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

    Lublin, 20-090
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny Nr W Lublinie

    Lublin, 20-090
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

    Wroclaw, 50-367
    Poland

    Active - Recruiting

  • Dong A University Hospital

    Seogu, Busan Gwang'yeogsi 49201
    South Korea

    Active - Recruiting

  • Kyungpook National University Hospital

    Junggu, Daegu Gwang'yeogsi 41944
    South Korea

    Active - Recruiting

  • National Cancer Center (Korea)

    IlsandongGu GoyangSi, Gyeonggi-do 10408
    South Korea

    Active - Recruiting

  • Chonnam National University Hwasun Hospital

    HwasunGun, Jeollanam-do 58128
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi 06351
    South Korea

    Active - Recruiting

  • The Catholic University of Korea, Seoul St Marys Hospital

    SeochoGu, Seoul Teugbyeolsi 06591
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi 03080
    South Korea

    Active - Recruiting

  • Gazi University

    Ankara, 6500
    Turkey

    Site Not Available

  • Antalya Memorial Hospital

    Dokuma, 07025
    Turkey

    Active - Recruiting

  • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Ankara, 06200
    Turkey (Türkiye)

    Active - Recruiting

  • Gazi University

    Ankara, 6500
    Turkey (Türkiye)

    Active - Recruiting

  • Gazi University

    Ankara 323786, 6500
    Turkey (Türkiye)

    Active - Recruiting

  • Dokuz Eylul University

    Balçova, 35330
    Turkey (Türkiye)

    Active - Recruiting

  • Antalya Memorial Hospital

    Dokuma, 07025
    Turkey (Türkiye)

    Active - Recruiting

  • Sakarya Training and Research Hospital

    Sakarya, 54100
    Turkey (Türkiye)

    Active - Recruiting

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN
    United Kingdom

    Active - Recruiting

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS
    United Kingdom

    Active - Recruiting

  • The Royal Bournemouth and Christchurch Hospitals Nhs Foundation

    Bournemouth, BH7 7DW
    United Kingdom

    Active - Recruiting

  • Royal Marsden Hospital

    London, SW3 6JJ
    United Kingdom

    Active - Recruiting

  • University College Hospital

    London, NW1 2PG
    United Kingdom

    Active - Recruiting

  • University College Hospital

    London 2643743, NW1 2PG
    United Kingdom

    Active - Recruiting

  • Nottingham University Hospitals Nhs Trust

    Nottingham, NG51PB
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Active - Recruiting

  • St Bernards Medical Center

    Jonesboro, Arkansas 72401
    United States

    Active - Recruiting

  • UCLA Department of Medicine Hematologyoncology

    Los Angeles, California 90095-3075
    United States

    Active - Recruiting

  • Pih Health Whittier Hospital

    Whittier, California 90602
    United States

    Active - Recruiting

  • Rocky Mountain Cancer Centers (Williams) Usor

    Aurora, Colorado 80012-5405
    United States

    Active - Recruiting

  • Florida Oncology and Hematology

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • Baptist Md Anderson Cancer Center

    Jacksonville, Florida 32207-8432
    United States

    Active - Recruiting

  • Cleveland Clinic Florida

    Weston, Florida 33331-3609
    United States

    Active - Recruiting

  • Emory University Winship Cancer Institute

    Atlanta, Georgia 30322-1013
    United States

    Active - Recruiting

  • Northside Cancer Center

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • Our Lady of the Lake Hospital

    Baton Rouge, Louisiana 70808-4365
    United States

    Active - Recruiting

  • American Oncology Partners of Maryland Pa

    Bethesda, Maryland 20817-7847
    United States

    Active - Recruiting

  • Oncology Hematology Associates

    Springfield, Missouri 65807-5288
    United States

    Active - Recruiting

  • Oncology Hematology West, Pc Dba Nebraska Cancer Specialists

    Omaha, Nebraska 68130-2042
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York, New York 10065-6800
    United States

    Active - Recruiting

  • Clinical Research Alliance, Inc

    Westbury, New York 11590-5119
    United States

    Active - Recruiting

  • University Hospitals

    Cleveland, Ohio 44106-1716
    United States

    Active - Recruiting

  • Dayton Physician Network

    Dayton, Ohio 45415
    United States

    Active - Recruiting

  • Oncology Associates of Oregon Willamette Valley Cancer Center

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • West Penn Hospital

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • Cancer Care Associates of York

    York, Pennsylvania 17403-5049
    United States

    Active - Recruiting

  • Texas Oncology Tyler

    Tyler, Texas 75702-7522
    United States

    Active - Recruiting

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