Trial record 1 of 1 for: phase 3 AND a+avd AND abvd

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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 December 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: December 23, 2014

Last verified: December 2014

History of Changes

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:

MedlinePlus related topics: Hodgkin Disease Lymphoma

Drug Information available for: Vinblastine sulfate Vinblastine Dacarbazine Bleomycin sulfate Bleomycin Doxorubicin Doxorubicin hydrochloride Brentuximab vedotin

Genetic and Rare Diseases Information Center resources: Hodgkin Lymphoma Lymphosarcoma

U.S. FDA Resources

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

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

Show 230 Study Locations

Sponsors and Collaborators

Millennium Pharmaceuticals, Inc.

Seattle Genetics, Inc.

Investigators


Study Director:	Medical Monitor	Millennium Pharmaceuticals, Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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:	December 23, 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 ECHELON-1

Additional relevant MeSH terms:


Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Doxorubicin Liposomal doxorubicin Vinblastine Antibiotics, Antineoplastic	Antimitotic Agents Antineoplastic Agents Antineoplastic Agents, Phytogenic Enzyme Inhibitors Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses Topoisomerase II Inhibitors Topoisomerase Inhibitors Tubulin Modulators

ClinicalTrials.gov processed this record on March 03, 2015

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