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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Millennium Pharmaceuticals, Inc.
Sponsor:
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01712490
First received: October 19, 2012
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

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)


Condition Intervention Phase
Hodgkin Lymphoma
Drug: brentuximab vedotin
Drug: doxorubicin
Drug: bleomycin
Drug: vinblastine
Drug: dacarbazine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Modified progression free survival (mPFS) per independent review facility (IRF) [ Time Frame: Date of randomization to mPFS event, for approximately 3 to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival rate [ Time Frame: Date of randomization to the date of death, for approximately 5 to 7 years ] [ Designated as safety issue: No ]
    Date of randomization to the date of death


Estimated Enrollment: 1040
Study Start Date: November 2012
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A + AVD
A+AVD consists of brentuximab vedotin (ADCETRIS®) 1.2 mg/kg plus doxorubicin 25 mg/m2, vinblastine 6 mg/m2, and dacarbazine (DTIC) 375 mg/m2
Drug: brentuximab vedotin
Brentuximab vedotin (ADCETRIS®)1.2 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle
Other Names:
  • ADCETRIS®
  • SGN-35
Drug: doxorubicin
Doxorubicin: 25 mg/m2 by IV infusion on Days 1 and 15 of each 28-day cycle
Other Name: Adriamycin
Drug: vinblastine
Vinblastine: 6 mg/m2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
Drug: dacarbazine
Dacarbazine (DTIC): 375 mg/m2 by IV infusion on Days 1 and 15 of each 28-day cycle
Other Name: DTIC
Active Comparator: ABVD
ABVD consists of doxorubicin 25 mg/m2, bleomycin 10 units/m2, vinblastine 6 mg/m2, and dacarbazine (DTIC) 375 mg/m2
Drug: doxorubicin
Doxorubicin: 25 mg/m2 by IV infusion on Days 1 and 15 of each 28-day cycle
Other Name: Adriamycin
Drug: bleomycin
Bleomycin: 10 units/m2 by IV infusion on Days 1 and 15 of each 28-day cycle
Drug: vinblastine
Vinblastine: 6 mg/m2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
Drug: dacarbazine
Dacarbazine (DTIC): 375 mg/m2 by IV infusion on Days 1 and 15 of each 28-day cycle
Other Name: DTIC

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712490

Contacts
Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center 1-877-674-3784 medical@mlnm.com

  Hide Study Locations
Locations
United States, California
Recruiting
Fresno, California, United States
Recruiting
Los Angeles, California, United States
Recruiting
Sacramento, California, United States
United States, Illinois
Recruiting
Niles, Illinois, United States
United States, Indiana
Recruiting
Goshen, Indiana, United States
United States, Kansas
Recruiting
Fairway, Kansas, United States
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States
United States, Michigan
Recruiting
Ann Arbor, Michigan, United States
United States, Minnesota
Recruiting
Minneapolis, Minnesota, United States
Recruiting
Rochester, Minnesota, United States
United States, Missouri
Recruiting
Springfield, Missouri, United States
United States, New Jersey
Recruiting
Morristown, New Jersey, United States
United States, New York
Recruiting
Albany, New York, United States
Recruiting
New York City, New York, United States
United States, North Carolina
Recruiting
Charlotte, North Carolina, United States
United States, Ohio
Recruiting
Columbus, Ohio, United States
United States, Oregon
Recruiting
Eugene, Oregon, United States
United States, Tennessee
Recruiting
Knoxville, Tennessee, United States
United States, Texas
Recruiting
Austin, Texas, United States
Recruiting
San Antonio, Texas, United States
Recruiting
Tyler, Texas, United States
United States, Utah
Recruiting
Salt Lake City, Utah, United States
United States, Virginia
Recruiting
Alexandria, Virginia, United States
United States, Washington
Recruiting
Seattle, Washington, United States
Recruiting
Vancouver, Washington, United States
Recruiting
Yakima, Washington, United States
Canada, Ontario
Recruiting
Toronto, Ontario, Canada
France
Recruiting
Argenteuil, Cedex, France
Recruiting
Limoges cedex, Limoges, France
Italy
Recruiting
Rome, Italy
Japan
Recruiting
Minami-ku, Fukuoka-city, Japan
Recruiting
Higashi-ku, Fukuoka, Japan
Recruiting
Minami-ku, Hiroshima-city, Japan
Recruiting
Showamachi, Maebashi-city, Japan
Recruiting
Chikusa-ku, Nagoya, Japan
Recruiting
Suita, Osaka Prefecture, Japan
Recruiting
Aoba-ku, Sendai-city, Japan
Recruiting
Chuo-ku, Japan
Recruiting
Isehara-shi, Japan
Recruiting
Koto-ku, Japan
Korea, Republic of
Recruiting
Seo-gu, Busan, Korea, Republic of
Recruiting
Hwasun-eup, Hwasun-gun, Korea, Republic of
Recruiting
Namdong-gu, Incheon, Korea, Republic of
Norway
Recruiting
Oslo, Norway
Poland
Recruiting
Katowice, Poland
South Africa
Recruiting
Gauteng, Johannesburg, South Africa
Turkey
Recruiting
Fatih, Istanbul, Turkey
Recruiting
Kurupelit, Samsun, Turkey
Recruiting
Ankara, Turkey
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Seattle Genetics, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01712490     History of Changes
Other Study ID Numbers: C25003, 2011-005450-60, U1111-1161-4937, 12/LO/1950, JapicCTI-142491
Study First Received: October 19, 2012
Last Updated: October 20, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Keywords provided by Millennium Pharmaceuticals, Inc.:
Hodgkin Lymphoma
Hodgkin's Lymphoma
Antibody, Monoclonal
Antibody-Drug Conjugate
Antigens, CD-30
Immunotherapy
Lymphoma
Lymphoma, Classical

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Antibodies, Monoclonal
Bleomycin
Doxorubicin
Liposomal doxorubicin
Vinblastine
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014