IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Trial record 1 of 1 for:
phase 3 AND a+avd AND abvd
Phase 3 Frontline Therapy Trial in Patients With Advanced Classical Hodgkin Lymphoma
This study is ongoing, but not recruiting participants.
Sponsor:
Millennium Pharmaceuticals, Inc.
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier:
NCT01712490
First received: October 19, 2012
Last updated: September 29, 2016
Last verified: September 2016
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Takeda ( 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 ]
Secondary Outcome Measures:
- 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
| Enrollment: | 1334 |
| 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:
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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Show 221 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712490
Show 221 Study Locations
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Seattle Genetics, Inc.
Investigators
| Study Director: | Medical Monitor | Millennium Pharmaceuticals, Inc. |
More Information
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 ) |
| Study First Received: | October 19, 2012 |
| Last Updated: | September 29, 2016 |
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 |
ClinicalTrials.gov processed this record on July 19, 2017