Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL)

Last updated: January 7, 2025
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Lymphoma

Lymphoma, B-cell

Treatment

Copanlisib (Aliqopa, BAY80-6946)

Placebo

Rituximab

Clinical Study ID

NCT02367040
17067
2013-003893-29
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study was to evaluate whether copanlisib in combination with rituximab is superior to placebo in combination with rituximab in prolonging progression free survival (PFS) in patients with relapsed iNHL who have received one or more lines of treatment, including rituximab and who either had a treatment-free interval of ≥ 12 months after completion of the last rituximab-containing treatment, or who are unwilling to receive chemotherapy/for whom chemotherapy is contraindicated on reason of age, comorbidities, and/or residual toxicity.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed diagnosis of Indolent non-Hodgkin's lymphoma (iNHL) in CD20positive patients, with histological subtype limited to:

  • Follicular lymphoma(FL) grade1-2-3a

  • Small lymphocytic lymphoma(SLL) with absolute lymphocyte count <5x10*9/L atstudy entry

  • Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)

  • Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)

  • Patients must have relapsed (recurrence after complete response or presentedprogression after partial response) after the last rituximab-, rituximabbiosimilars-, or anti-CD20 monoclonal antibody (e.g. obinutuzumab)-containingtherapy (other previous treatment lines after rituximab are allowed). A previousregimen is defined as one of the following: at least 2 months of single-agenttherapy (less than 2 months of therapy is allowed for patients who responded tosingle-agent rituximab, rituximab biosimilars, or anti-CD20 monoclonal antibody); atleast 2 consecutive cycles of polychemotherapy; autologous transplant;radioimmunotherapy. Previous exposure to PI3K is acceptable (except to copanlisib)provided there is no resistance. Patients with prior intolerance to PI3K inhibitorsother than copanlisib are eligible.

  • Non-WM must have at least one bi-dimensionally measurable lesion (which has not beenpreviously irradiated) according to the Lugano Classification. For patients withsplenic MZL (Marginal-zone lymphoma) this requirement may be restricted tosplenomegaly alone since that is usually the only manifestation of measurabledisease.

  • Patients affected by WM who do not have at least one bi-dimensionally measurablelesion in the baseline radiologic assessment must have measurable disease, definedas presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level ≥ 2 xupper limit of normal (ULN) and positive immunofixation test .

  • Male or female patients ≥ 18 years of age

  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

  • Life expectancy of at least 3 months

  • Availability of fresh tumor tissue and/or archival tumor tissue for centralpathology(obtained within 5 years of the consent date) at Screening

  • Adequate baseline laboratory values collected no more than 7 days before startingstudy treatment

  • Left ventricular ejection fraction ≥ 45%

  • Patients must either:

  • have had a progression-free and treatment-free interval of at least 12 monthsafter completion of the rituximab-, rituximab biosimilars-, or anti-CD20monoclonal antibody-containing treatment OR

  • be considered unfit to receive chemotherapy on reason of age, concomitantmorbidities, and/or residual toxicity from previous treatments, orunwillingness to receive chemotherapy. These patients must also have had aprogression-free and treatment-free interval of at least 6 months aftercompletion of the last rituximab-, rituximab biosimilars-, or anti-CD20monoclonal antibody-containing treatment. Patients in whom chemotherapy iscontraindicated are defined by one of the following features:

  • Age ≥ 80 years

  • Age < 80 years and at least 1 of the following conditions:

  • at least 3 grade 3 CIRS-G comorbidities OR

  • at least 1 grade 4 CIRS-G comorbidity (if compatible to participationin the study).

Exclusion

Exclusion Criteria:

  • Histologically confirmed diagnosis of follicular lymphoma grade 3b or transformeddisease, or chronic lymphocytic leukemia

  • Progression free interval or treatment free interval of less than 12 months sincethe last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody (e.g.obinutuzumab)-containing treatment(including maintenance with these drugs). Forpatients considered unwilling/unfit to receive chemotherapy : progression freeinterval or treatment free interval of less than 6 months since the last rituximab-,rituximab biosimilars-, or anti-CD20 monoclonal antibody-containing treatment (including maintenance with these drugs), as assessed by the investigator

  • History or concurrent condition of interstitial lung disease of any severity and/orseverely impaired lung function

  • Known lymphomatous involvement of the central nervous system

  • Patients with HbA1c > 8.5% at Screening

  • Known history of human immunodeficiency virus (HIV) infection

  • Hepatitis B (HBV) or hepatitis C (HCV). Patients positive for HBsAg or HBcAb will beeligible if they are negative for HBV-DNA, these patients should receiveprophylactic antiviral therapy. Patients positive for anti- HCV antibody will beeligible if they are negative for HCV-RNA

  • Documented evidence of resistance to prior treatment with idelalisib or other PI3Kinhibitors.

  • Prior treatment with copanlisib

  • Cytomegalovirus (CMV) infection. Patients who are CMV PCR positive at baseline willnot be eligible.

Study Design

Total Participants: 458
Treatment Group(s): 3
Primary Treatment: Copanlisib (Aliqopa, BAY80-6946)
Phase: 3
Study Start date:
August 03, 2015
Estimated Completion Date:
November 15, 2024

Connect with a study center

  • Buenos Aires, Ciudad Auton. De Buenos Aires TBC
    Argentina

    Site Not Available

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    Cordoba, Ciudad Auton. de Buenos Aires X5000JHQ
    Argentina

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  • Rosario, Santa Fe S2000DEJ
    Argentina

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  • San Miguel de Tucumán, Tucuman T4000
    Argentina

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  • empty

    Ciudad Auton. de Buenos Aires, C1114AAN
    Argentina

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  • Córdoba, X5000AOQ
    Argentina

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  • empty

    Kogarah, New South Wales 2217
    Australia

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    Orange, New South Wales 2800
    Australia

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    Waratah, New South Wales 2298
    Australia

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  • Ballarat, Victoria 3350
    Australia

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  • empty

    Kingswood, 2747
    Australia

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  • Nedlands, 6009
    Australia

    Site Not Available

  • Graz, Steiermark 8036
    Austria

    Site Not Available

  • empty

    Leoben, Steiermark 8700
    Austria

    Site Not Available

  • Landeskrankenhaus Rankweil

    Rankweil, Vorarlberg 6830
    Austria

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    Innsbruck, 6020
    Austria

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    Krems, 3500
    Austria

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    Linz, 4020
    Austria

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    Salzburg, 5020
    Austria

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  • Wien, 1090
    Austria

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  • empty

    Lesnoy, 223040
    Belarus

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    Minsk, 220013
    Belarus

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    Bruxelles - Brussel, 1020
    Belgium

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    Gent, 9000
    Belgium

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    Kortrijk, 8500
    Belgium

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  • Ottignies, 1340
    Belgium

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    Turnhout, 2300
    Belgium

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    Verviers, 4800
    Belgium

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  • Passo Fundo, Rio Grande Do Sul 99020-240
    Brazil

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  • Porto Alegre, Rio Grande Do Sul 90850-170
    Brazil

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    Ijuí, Rio Grande do Sul 98700-000
    Brazil

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    Barretos, Sao Paulo 14784-400
    Brazil

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  • Barretos, Sao Paulo 14784-400
    Brazil

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  • Barretos/SP, Sao Paulo 14784-400
    Brazil

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  • Jaú, Sao Paulo 17210-120
    Brazil

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  • São Paulo, Sao Paulo 08270-070
    Brazil

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    Brazil,
    Brazil

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    Rio de Janeiro, 22793-080
    Brazil

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    Brazil

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    Bulgaria

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  • Sofia, 1756
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  • Varna, 9010
    Bulgaria

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    Chile

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    Santiago, 833-0024
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    Zhengzhou, Henan 450052
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    Changchun, Jilin 130000
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    Yibin, Sichuan 644000
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    Urumchi, Xinjiang
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    Bogotá, Cundinamarca 111511
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  • Montería, Córdoba 230002
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    Bucaramanga, Santander
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    Floridablanca, Santander 681004
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    Denmark

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    Chemnitz, Sachsen 09116
    Germany

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    Germany

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    Halle (Saale), Sachsen-Anhalt 06097
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    Hamburg, 22081
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    Ulm, 89081
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    Haidari, Attica 12462
    Greece

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    Larissa, 41100
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    Patra, 26500
    Greece

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  • Patras, 26500
    Greece

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    Piraeus, 18 537
    Greece

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    Rio / Patra, 26500
    Greece

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    Thessaloniki, 570 10
    Greece

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  • Chai Wan, 0
    Hong Kong

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  • Hong Kong, MISSING
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    Kowloon,
    Hong Kong

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    New Territories,
    Hong Kong

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    Shatin, MISSING
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  • Shatin,
    Hong Kong

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  • Budapest, 1083
    Hungary

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  • Gyor, 9024
    Hungary

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    Hungary

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  • Pecs, 7623
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    Tata, 2890
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  • Tatabanya, 2800
    Hungary

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    Ireland

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    Dublin 4,
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    Ireland

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    Pordenone, Friuli-Venezia Giulia 33081
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  • Genova, Liguria 16132
    Italy

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  • Milano, Lombardia 20133
    Italy

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    Rozzano, Milano 20089
    Italy

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    Aviano, Pordenone 33081
    Italy

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  • Firenze, Toscana 50134
    Italy

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    Bergamo, 24127
    Italy

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    Bologna, 40138
    Italy

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    Cagliari, 09121
    Italy

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  • Nagoya, Aichi 466-8650
    Japan

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    Matsuyama, Ehime 791-0280
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  • Maebashi, Gunma 371-8511
    Japan

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    Akashi, Hyogo 673-8558
    Japan

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  • Kobe, Hyogo 650-0047
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  • Nankoku, Kochi 783-8505
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    Tsu, Mie 514-8507
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  • Sendai, Miyagi 980-8574
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    Matsumoto, Nagano 390-8621
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  • Omura, Nagasaki 856-8562
    Japan

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  • Kurashiki, Okayama 710-8602
    Japan

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  • Hirakata, Osaka 573-1191
    Japan

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    Moriguchi, Osaka 570-8540
    Japan

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  • Izumo, Shimane 693-8501
    Japan

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    Shimotsuke, Tochigi 329-0498
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    Komae, Tokyo 201-8601
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    Shinagawa-ku, Tokyo 141-8625
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  • Aomori, 030-8553
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    Chiba, 260-8717
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    Okayama, 700-8558
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  • Osaka, 545-8586
    Japan

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  • Yamagata, 990-9585
    Japan

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  • Seoul, Seoul Teugbyeolsi 03722
    Korea, Republic of

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  • Busan, 49201
    Korea, Republic of

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  • Hwasun Gun, 58128
    Korea, Republic of

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    Jeollanam-do, 58128
    Korea, Republic of

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  • Jeollanam-do, 58128
    Korea, Republic of

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  • Kaunas, LT-50009
    Lithuania

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    Esch-sur-alzette, 4240
    Luxembourg

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    Luxembourg, 1210
    Luxembourg

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  • Cheras, 56000
    Malaysia

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    Ipoh,
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    Kelantan,
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  • Pulau Pinang, 10450
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    México, D.F., Distrito Federal 06720
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    Russian Federation

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    Russian Federation

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    Russian Federation

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    Russian Federation

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    Russian Federation

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    Russian Federation

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    Singapore

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  • Poprad, 058 01
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    South Africa

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  • Johannesburg, Gauteng 2013
    South Africa

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    Pretoria, Gauteng 0044
    South Africa

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    South Africa

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    Fayetteville, Arkansas 72703
    United States

    Site Not Available

  • empty

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • empty

    Rogers, Arkansas 72758
    United States

    Site Not Available

  • empty

    Bakersfield, California 93309
    United States

    Site Not Available

  • empty

    Long Beach, California 90813
    United States

    Site Not Available

  • West Covina, California 91790
    United States

    Site Not Available

  • empty

    Whittier, California 90602
    United States

    Site Not Available

  • empty

    Denver, Colorado 80218
    United States

    Site Not Available

  • empty

    Hartford, Connecticut 06102-5037
    United States

    Site Not Available

  • empty

    Miami, Florida 33176
    United States

    Site Not Available

  • empty

    Orange City, Florida 32763
    United States

    Site Not Available

  • empty

    Columbus, Georgia 31904
    United States

    Site Not Available

  • empty

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Ashland, Kentucky 41101
    United States

    Site Not Available

  • Louisville, Kentucky 40207
    United States

    Site Not Available

  • Bethesda, Maryland 20817
    United States

    Site Not Available

  • empty

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • empty

    Owosso, Michigan 48867
    United States

    Site Not Available

  • Las Vegas, Nevada 89169
    United States

    Site Not Available

  • empty

    Basking Ridge, New Jersey 07920
    United States

    Site Not Available

  • empty

    Englewood, New Jersey 07361
    United States

    Site Not Available

  • empty

    Middletown, New Jersey 07748
    United States

    Site Not Available

  • empty

    Montvale, New Jersey 07645
    United States

    Site Not Available

  • empty

    Morristown, New Jersey 07962-1956
    United States

    Site Not Available

  • MSK Basking Ridge

    New Jersey, New Jersey
    United States

    Site Not Available

  • MSK Bergen

    New Jersey, New Jersey
    United States

    Site Not Available

  • MSK Monmoth

    New Jersey, New Jersey
    United States

    Site Not Available

  • empty

    Commack, New York 11725
    United States

    Site Not Available

  • MSK Westchester

    Harrison, New York
    United States

    Site Not Available

  • MSK Commack

    Long Island City, New York
    United States

    Site Not Available

  • MSK Rockville Centre

    Long Island City, New York
    United States

    Site Not Available

  • New York, New York 10065
    United States

    Site Not Available

  • empty

    Rockville Center, New York 11570
    United States

    Site Not Available

  • empty

    Uniondale, New York 11553
    United States

    Site Not Available

  • empty

    Goldsboro, North Carolina 27534
    United States

    Site Not Available

  • Canton, Ohio 44718
    United States

    Site Not Available

  • empty

    Cleveland, Ohio 44106-2602
    United States

    Site Not Available

  • empty

    Bend, Oregon 97701
    United States

    Site Not Available

  • empty

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • empty

    Danville, Pennsylvania 17822-2001
    United States

    Site Not Available

  • empty

    Watertown, South Dakota 57201
    United States

    Site Not Available

  • empty

    San Antonio, Texas 78235
    United States

    Site Not Available

  • Salt Lake City, Utah 84106
    United States

    Site Not Available

  • empty

    Olympia, Washington 98506
    United States

    Site Not Available

  • Spokane, Washington 99208-1129
    United States

    Site Not Available

  • Ha Noi, 10000
    Vietnam

    Site Not Available

  • Ho Chi Minh City, 70000
    Vietnam

    Site Not Available

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