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Trial record 1 of 1 for:    millennium C25003
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Phase 3 Frontline Therapy Trial in Patients With Advanced Classical Hodgkin Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01712490
First Posted: October 23, 2012
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )
October 19, 2012
October 23, 2012
August 1, 2017
November 1, 2012
April 20, 2017   (Final data collection date for primary outcome measure)
Modified progression free survival (mPFS) per independent review facility (IRF) [ Time Frame: Date of randomization to mPFS event, for approximately 3 to 5 years ]
Same as current
Complete list of historical versions of study NCT01712490 on ClinicalTrials.gov Archive Site
Overall survival rate [ Time Frame: Date of randomization to the date of death, for approximately 5 to 7 years ]
Date of randomization to the date of death
Same as current
Not Provided
Not Provided
 
Phase 3 Frontline Therapy Trial in Patients With Advanced Classical Hodgkin Lymphoma
A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
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)
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hodgkin Lymphoma
  • 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: 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
  • 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
    Interventions:
    • Drug: brentuximab vedotin
    • Drug: doxorubicin
    • Drug: vinblastine
    • Drug: dacarbazine
  • Active Comparator: ABVD
    ABVD consists of doxorubicin 25 mg/m2, bleomycin 10 units/m2, vinblastine 6 mg/m2, and dacarbazine (DTIC) 375 mg/m2
    Interventions:
    • Drug: doxorubicin
    • Drug: bleomycin
    • Drug: vinblastine
    • Drug: dacarbazine
Younes A, Connors JM, Park SI, Fanale M, O'Meara MM, Hunder NN, Huebner D, Ansell SM. Brentuximab vedotin combined with ABVD or AVD for patients with newly diagnosed Hodgkin's lymphoma: a phase 1, open-label, dose-escalation study. Lancet Oncol. 2013 Dec;14(13):1348-56. doi: 10.1016/S1470-2045(13)70501-1. Epub 2013 Nov 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1334
March 1, 2020
April 20, 2017   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Brazil,   Canada,   Czechia,   Denmark,   France,   Hong Kong,   Hungary,   Italy,   Japan,   Korea, Republic of,   Norway,   Poland,   Russian Federation,   South Africa,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Czech Republic
 
NCT01712490
C25003
2011-005450-60 ( EudraCT Number )
U1111-1161-4937 ( Registry Identifier: WHO )
12/LO/1950 ( Registry Identifier: NRES )
JapicCTI-142491 ( Registry Identifier: JapicCTI )
REec-2013-0114 ( Registry Identifier: REec )
1025002760 ( Registry Identifier: TCTIN )
C25003CTID ( Other Identifier: Israel )
Yes
Not Provided
Not Provided
Takeda ( Millennium Pharmaceuticals, Inc. )
Millennium Pharmaceuticals, Inc.
Seattle Genetics, Inc.
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Takeda
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP