Non Hodgkin Lymphoma Clinical Trial

A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma

Summary

This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Treatment-naïve participants with Ann Arbor Stage III or IV HL.
Histologically confirmed classical Hodgkin Lymphoma (HL) according to the current World Health Organization (WHO) classification.
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 2.
Bidimensional measurable disease as documented by radiographic technique per the International Working Group Revised Criteria for Response Assessment for Malignant Lymphoma.

Exclusion Criteria:

Nodular lymphocyte predominant Hodgkin lymphoma.
Cerebral/meningeal disease, including signs and symptoms of progressive multifocalleukoencephalopathy (PML).
Sensory or motor peripheral neuropathy.
Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 12 weeks of first study drug dose.
Known human immunodeficiency virus (HIV) positive.
Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.

Please note that there are additional exclusion criteria. The study center will determine if you meet all of the criteria.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

1334

Study ID:

NCT01712490

Recruitment Status:

Active, not recruiting

Sponsor:

Takeda

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There is 1 Location for this study

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Birmingham Alabama, , United States

Gilbert Arizona, , United States

Tucson Arizona, , United States

Burbank California, , United States

Duarte California, , United States

Fresno California, , United States

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La Jolla California, , United States

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Denver Colorado, , United States

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Washington District of Columbia, , United States

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Jacksonville Florida, , United States

Miami Florida, , United States

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Lawrenceville Georgia, , United States

Chicago Illinois, , United States

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Niles Illinois, , United States

Zion Illinois, , United States

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Goshen Indiana, , United States

Indianapolis Indiana, , United States

Iowa City Iowa, , United States

Fairway Kansas, , United States

Baltimore Maryland, , United States

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Rochester Minnesota, , United States

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Lincoln Nebraska, , United States

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Morristown New Jersey, , United States

Albuquerque New Mexico, , United States

Albany New York, , United States

Bronx New York, , United States

Commack New York, , United States

New York New York, , United States

Rochester New York, , United States

Rockville Centre New York, , United States

Charlotte North Carolina, , United States

Raleigh North Carolina, , United States

Bismarck North Dakota, , United States

Cincinnati Ohio, , United States

Columbus Ohio, , United States

Oklahoma City Oklahoma, , United States

Eugene Oregon, , United States

Hershey Pennsylvania, , United States

Philadelphia Pennsylvania, , United States

Charleston South Carolina, , United States

Greenville South Carolina, , United States

Chattanooga Tennessee, , United States

Knoxville Tennessee, , United States

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Austin Texas, , United States

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Salt Lake City Utah, , United States

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Seattle Washington, , United States

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Milwaukee Wisconsin, , United States

Kingswood New South Wales, , Australia

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South Brisbane Queensland, , Australia

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Perth Western Australia, , Australia

Antwerpen , , Belgium

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Gent , , Belgium

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Edmonton Alberta, , Canada

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Prague , , Czechia

Praha 10 , , Czechia

Aalborg , , Denmark

Aarhus C , , Denmark

Copenhagen , , Denmark

Odense C , , Denmark

Roskilde , , Denmark

Argenteuil Cedex, , France

La Tronche , , France

Limoges , , France

Paris , , France

Lai Chi Kok Kowloon, , Hong Kong

Hong Kong , , Hong Kong

Tuen Mun , , Hong Kong

Budapest , , Hungary

Debrecen , , Hungary

Gyor , , Hungary

Pecs , , Hungary

Szeged , , Hungary

Modena Emilia-Romagna, , Italy

Roma Lazio, , Italy

Alessandria , , Italy

Bologna , , Italy

Cagliari , , Italy

Cuneo , , Italy

Genova , , Italy

Milano , , Italy

Napoli , , Italy

Rionero In Volture , , Italy

Rome , , Italy

Rozzano , , Italy

Torrette Di Ancona , , Italy

Minami-ku Fukuoka-city, , Japan

Higashi-ku Fukuoka, , Japan

Minami-ku Hiroshima-city, , Japan

Showamachi Maebashi-city, , Japan

Chikusa-ku Nagoya, , Japan

Suita Osaka Prefecture, , Japan

Aoba-ku Sendai-city, , Japan

Chuo-ku , , Japan

Isehara-shi , , Japan

Koto-ku , , Japan

Goyang Gyeonggi, , Korea, Republic of

Hwasun-gun Jeollanam-do, , Korea, Republic of

Seocho-gu Seoul, , Korea, Republic of

Busan , , Korea, Republic of

Daegu , , Korea, Republic of

Incheon , , Korea, Republic of

Jeonju , , Korea, Republic of

Seoul , , Korea, Republic of

Bergen , , Norway

Oslo , , Norway

Gdansk , , Poland

Katowice , , Poland

Krakow , , Poland

L0dz , , Poland

Olsztyn , , Poland

Warszawa , , Poland

Wroclaw , , Poland

Saint-Petersburg Poselok Pesochny, , Russian Federation

Ufa Republic Of Bashkortostan, , Russian Federation

Kazan Republic Tatrstan, , Russian Federation

Moscow , , Russian Federation

Moskva , , Russian Federation

St.Petersburg , , Russian Federation

Johannesburg Gauteng, , South Africa

Pretoria Gauteng, , South Africa

Amanzimtoti Kwa Zulu Natal, , South Africa

Bloemfontein , , South Africa

Cape Town , , South Africa

Badalona , , Spain

Barcelona , , Spain

Marbella , , Spain

Pamplona , , Spain

Salamanca , , Spain

Santiago de Compostela , , Spain

Valencia , , Spain

Changhua City , , Taiwan

Chiayi County 613 , , Taiwan

Tainan , , Taiwan

Taipei , , Taiwan

Taoyuan County , , Taiwan

Ankara , , Turkey

Istanbul , , Turkey

Samsun , , Turkey

Truro Cornwall, , United Kingdom

Aberdeen Scotland, , United Kingdom

Glasgow Scotland, , United Kingdom

Sutton Surrey, , United Kingdom

Cardiff Wales, , United Kingdom

Birmingham , , United Kingdom

Canterbury , , United Kingdom

Exeter , , United Kingdom

Inverness , , United Kingdom

Leicester , , United Kingdom

Lincoln , , United Kingdom

Liverpool , , United Kingdom

London , , United Kingdom

Manchester , , United Kingdom

Norfolk , , United Kingdom

Northwood , , United Kingdom

Nottingham , , United Kingdom

Oxford , , United Kingdom

Romford , , United Kingdom

Southampton , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

1334

Study ID:

NCT01712490

Recruitment Status:

Active, not recruiting

Sponsor:


Takeda

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