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Phase 3 Frontline Therapy Trial in Patients With Advanced Classical Hodgkin Lymphoma

Information source: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hodgkin Lymphoma

Intervention: brentuximab vedotin (Drug); doxorubicin (Drug); bleomycin (Drug); vinblastine (Drug); dacarbazine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Millennium Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Millennium Pharmaceuticals, Inc.

Overall contact:
Takeda Study Registration Call Center, Phone: +1-866-835-2233, Email: medical@mlnm.com

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)

Clinical Details

Official title: A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Modified progression free survival (mPFS) per independent review facility (IRF)

Secondary outcome: Overall survival rate

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Treatment-naïve

- Histologically confirmed classical Hodgkin Lymphoma (HL)

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

- Bidimensional measurable disease

Exclusion Criteria:

- Nodular lymphocyte predominant Hodgkin lymphoma

- Cerebral/meningeal disease, including signs and symptoms of progressive multifocal

leukoencephalopathy (PML)

- Pulmonary diffusion capacity > 25% lower than normal predicted value

- Sensory or motor peripheral neuropathy

- 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.

Locations and Contacts

Takeda Study Registration Call Center, Phone: +1-866-835-2233, Email: medical@mlnm.com

Antwerpen, Belgium; Recruiting

Brugge, Belgium; Recruiting

Gent, Belgium; Recruiting

Rio De Janeiro, Brazil; Recruiting

Sao paulo, Brazil; Recruiting

Hradec Kralove, Czech Republic; Recruiting

Prague, Czech Republic; Recruiting

Praha 10, Czech Republic; Recruiting

Aalborg, Denmark; Recruiting

Aarhus C, Denmark; Recruiting

Copenhagen, Denmark; Recruiting

Herlev, Denmark; Recruiting

Odense C, Denmark; Recruiting

Roskilde, Denmark; Recruiting

La Tronche, France; Recruiting

Limoges, France; Recruiting

Hong Kong, Hong Kong; Not yet recruiting

Budapest, Hungary; Recruiting

Debrecen, Hungary; Recruiting

Gyor, Hungary; Not yet recruiting

Pecs, Hungary; Recruiting

Szeged, Hungary; Recruiting

Alessandria, Italy; Recruiting

Bologna, Italy; Recruiting

Cagliari, Italy; Recruiting

Cuneo, Italy; Not yet recruiting

Genova, Italy; Recruiting

Milano, Italy; Recruiting

Napoli, Italy; Recruiting

Rionero in Volture, Italy; Recruiting

Rome, Italy; Recruiting

Rozzano Milano, Italy; Recruiting

Torrette di Ancona, Italy; Recruiting

Chuo-ku, Japan; Recruiting

Isehara-shi, Japan; Recruiting

Koto-ku, Japan; Not yet recruiting

Busan, Korea, Republic of; Recruiting

Daegu, Korea, Republic of; Recruiting

Incheon, Korea, Republic of; Recruiting

Jeonju, Korea, Republic of; Recruiting

Seoul, Korea, Republic of; Recruiting

Bergen, Norway; Not yet recruiting

Oslo, Norway; Recruiting

Gdansk, Poland; Recruiting

Katowice, Poland; Recruiting

Krakow, Poland; Recruiting

L0dz, Poland; Recruiting

Olsztyn, Poland; Recruiting

Warszawa, Poland; Recruiting

Wroclaw, Poland; Not yet recruiting

Bloemfontein, South Africa; Not yet recruiting

Cape Town, South Africa; Recruiting

Johannesburg, South Africa; Not yet recruiting

Badalona, Spain; Recruiting

Barcelona, Spain; Recruiting

Marbella, Spain; Recruiting

Pamplona, Spain; Recruiting

Salamanca, Spain; Recruiting

Santiago de Compostela, Spain; Recruiting

Valencia, Spain; Recruiting

Changhua City, Taiwan; Recruiting

Chiayi County 613,, Taiwan; Recruiting

Tainan, Taiwan; Recruiting

Taipei, Taiwan; Recruiting

Taoyuan County, Taiwan; Recruiting

Ankara, Turkey; Recruiting

Istanbul, Turkey; Recruiting

Samsun, Turkey; Recruiting

Birmingham, United Kingdom; Not yet recruiting

Canterbury, United Kingdom; Recruiting

Exeter, United Kingdom; Recruiting

Inverness, United Kingdom; Recruiting

Leicester, United Kingdom; Recruiting

Lincoln, United Kingdom; Not yet recruiting

Liverpool, United Kingdom; Recruiting

London, United Kingdom; Recruiting

Manchester, United Kingdom; Recruiting

Norfolk, United Kingdom; Recruiting

Northwood, Middx, United Kingdom; Recruiting

Nottingham, United Kingdom; Recruiting

Oxford, United Kingdom; Recruiting

Romford, United Kingdom; Recruiting

Southampton, United Kingdom; Recruiting

Birmingham, Alabama, United States; Recruiting

Edmonton, Alberta, Canada; Recruiting

Gilbert, Arizona, United States; Recruiting

Tucson, Arizona, United States; Not yet recruiting

Salvador, Bahia, Brazil; Recruiting

Vancouver, British Columbia, Canada; Recruiting

Burbank, California, United States; Not yet recruiting

Duarte, California, United States; Recruiting

Fresno, California, United States; Not yet recruiting

Fullerton, California, United States; Recruiting

La Jolla, California, United States; Recruiting

Long Beach, California, United States; Recruiting

Los Angeles, California, United States; Recruiting

Sacramento, California, United States; Recruiting

San Luis Obispo, California, United States; Recruiting

Santa Barbara, California, United States; Recruiting

Santa Monica, California, United States; Recruiting

Stanford, California, United States; Recruiting

Argenteuil, Cedex, France; Recruiting

Lonetree, Colorado, United States; Recruiting

Truro, Cornwall, United Kingdom; Recruiting

Washington, District of Columbia, United States; Recruiting

Modena, Emilia-Romagna, Italy; Recruiting

Fort Myers, Florida, United States; Recruiting

Jacksonville, Florida, United States; Recruiting

Miami, Florida, United States; Recruiting

Orlando, Florida, United States; Recruiting

Higashi-ku, Fukuoka, Japan; Recruiting

Minami-ku, Fukuoka-city, Japan; Recruiting

Johannesburg, Gauteng, South Africa; Not yet recruiting

Johannesburg, Gauteng, South Africa; Recruiting

Pretoria, Gauteng, South Africa; Not yet recruiting

Lawrenceville, Georgia, United States; Not yet recruiting

Goyang, Gyeonggi, Korea, Republic of; Recruiting

Minami-ku, Hiroshima-city, Japan; Not yet recruiting

Chicago, Illinois, United States; Recruiting

Maywood, Illinois, United States; Recruiting

Niles, Illinois, United States; Recruiting

Zion, Illinois, United States; Recruiting

Fort Wayne, Indiana, United States; Not yet recruiting

Goshen, Indiana, United States; Recruiting

Indianapolis, Indiana, United States; Recruiting

Iowa City, Iowa, United States; Recruiting

Hwasun-gun, Jeollanam-do, Korea, Republic of; Not yet recruiting

Fairway, Kansas, United States; Recruiting

Lai Chi Kok, Kowloon, Hong Kong; Recruiting

Amanzimtoti, Kwa Zulu Natal, South Africa; Not yet recruiting

Roma, Lazio, Italy; Recruiting

Showamachi, Maebashi-city, Japan; Recruiting

Winnipeg, Mb, Manitoba, Canada; Recruiting

Baltimore, Maryland, United States; Recruiting

Bethesda, Maryland, United States; Recruiting

Boston, Massachusetts, United States; Recruiting

Ann Arbor, Michigan, United States; Recruiting

Detroit, Michigan, United States; Recruiting

Minneapolis, Minnesota, United States; Not yet recruiting

Minneapolis, Minnesota, United States; Recruiting

Rochester, Minnesota, United States; Recruiting

Springfield, Missouri, United States; Recruiting

St. Louis, Missouri, United States; Recruiting

Chikusa-ku, Nagoya, Japan; Recruiting

Lincoln, Nebraska, United States; Not yet recruiting

Omaha, Nebraska, United States; Recruiting

Las Vegas, Nevada, United States; Recruiting

Basking Ridge, New Jersey, United States; Not yet recruiting

Hackensack, New Jersey, United States; Recruiting

Morristown, New Jersey, United States; Recruiting

Albuquerque, New Mexico, United States; Recruiting

Kingswood, New South Wales, Australia; Recruiting

St Leonards, New South Wales, Australia; Recruiting

Westmead, New South Wales, Australia; Recruiting

Albany, New York, United States; Recruiting

Bronx, New York, United States; Recruiting

Commack, New York, United States; Recruiting

New York City, New York, United States; Recruiting

New York, New York, United States; Recruiting

New York, New York, United States; Not yet recruiting

NYC, New York, United States; Recruiting

Rochester, New York, United States; Recruiting

Rockville Centre, New York, United States; Recruiting

Charlotte, North Carolina, United States; Recruiting

Raleigh, North Carolina, United States; Recruiting

Halifax, Nova Scotia, Canada; Recruiting

Cincinnati, Ohio, United States; Recruiting

Columbus, Ohio, United States; Recruiting

Oklahoma City, Oklahoma, United States; Not yet recruiting

Toronto, Ontario, Canada; Recruiting

Eugene, Oregon, United States; Recruiting

Suita, Osaka Prefecture, Japan; Recruiting

Curitiba, Parana, Brazil; Not yet recruiting

Hershey, Pennsylvania, United States; Recruiting

Philadelphia, Pennsylvania, United States; Recruiting

Philadelphia, Pennsylvania, United States; Not yet recruiting

Montreal, Quebec, Canada; Recruiting

South Brisbane, Queensland, Australia; Recruiting

Ufa, Republic of Bashkortostan, Russian Federation; Recruiting

Porto Alegre, Rio Grande do Sul, Brazil; Recruiting

Santo Andre, Sao Paulo, Brazil; Recruiting

Saskatoon, Saskatchewan, Canada; Recruiting

Aberdeen, Scotland, United Kingdom; Recruiting

Glasgow, Scotland, United Kingdom; Recruiting

Aoba-ku, Sendai-city, Japan; Recruiting

Seocho-gu, Seoul, Korea, Republic of; Recruiting

Bedford Park, South Australia, Australia; Recruiting

Charleston, South Carolina, United States; Recruiting

Greenville, South Carolina, United States; Recruiting

Sutton, Surrey, United Kingdom; Recruiting

Hobart, Tasmania, Australia; Recruiting

Chattanooga, Tennessee, United States; Recruiting

Knoxville, Tennessee, United States; Recruiting

Nashville, Tennessee, United States; Recruiting

Austin, Texas, United States; Recruiting

Dallas, Texas, United States; Recruiting

Houston, Texas, United States; Recruiting

San Antonio, Texas, United States; Recruiting

Tyler, Texas, United States; Recruiting

Salt Lake City, Utah, United States; Recruiting

Salt Lake City, Utah, United States; Not yet recruiting

East Melbourne, Victoria, Australia; Recruiting

Geelong, Victoria, Australia; Recruiting

Heidelberg, Victoria, Australia; Recruiting

Parkville, Victoria, Australia; Recruiting

Fairfax, Virginia, United States; Not yet recruiting

Richmond, Virginia, United States; Not yet recruiting

Cardiff, Wales, United Kingdom; Recruiting

Kennewick, Washington, United States; Recruiting

Seattle, Washington, United States; Recruiting

Vancouver, Washington, United States; Not yet recruiting

Yakima, Washington, United States; Recruiting

Morgantown, West Virginia, United States; Recruiting

Perth, Western Australia, Australia; Recruiting

Milwaukee, Wisconsin, United States; Recruiting

Additional Information

Starting date: November 2012
Last updated: April 30, 2015

Page last updated: August 23, 2015

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