Phase 3 Frontline Therapy Trial in Patients With Advanced Classical Hodgkin Lymphoma
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ClinicalTrials.gov Identifier: NCT01712490 |
Recruitment Status
:
Active, not recruiting
First Posted
: October 23, 2012
Last Update Posted
: August 1, 2017
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Condition or disease | Intervention/treatment | Phase |
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Hodgkin Lymphoma | Drug: brentuximab vedotin Drug: doxorubicin Drug: bleomycin Drug: vinblastine Drug: dacarbazine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1334 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Actual Study Start Date : | November 1, 2012 |
Actual Primary Completion Date : | April 20, 2017 |
Estimated Study Completion Date : | March 1, 2020 |
Arm | Intervention/treatment |
---|---|
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
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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:
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
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Active Comparator: ABVD
ABVD consists of doxorubicin 25 mg/m2, bleomycin 10 units/m2, vinblastine 6 mg/m2, and dacarbazine (DTIC) 375 mg/m2
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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
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- Modified progression free survival (mPFS) per independent review facility (IRF) [ Time Frame: Date of randomization to mPFS event, for approximately 3 to 5 years ]
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01712490

Study Director: | Medical Monitor | Millennium Pharmaceuticals, Inc. |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Millennium Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT01712490 History of Changes |
Other Study ID Numbers: |
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 ) |
First Posted: | October 23, 2012 Key Record Dates |
Last Update Posted: | August 1, 2017 |
Last Verified: | July 2017 |
Keywords provided by Takeda ( Millennium Pharmaceuticals, Inc. ):
Hodgkin Lymphoma Hodgkins Lymphoma Antibody, Monoclonal Antibody-Drug Conjugate Antigens, CD-30 |
Immunotherapy Lymphoma Lymphoma, Classical ECHELON-1 |
Additional relevant MeSH terms:
Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Antibodies Antibodies, Monoclonal Doxorubicin Liposomal doxorubicin Bleomycin |
Vinblastine Immunologic Factors Physiological Effects of Drugs Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |