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.
ClinicalTrials.gov Identifier:
NCT01712490
First Posted: October 23, 2012
Last Update Posted: August 1, 2017
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )
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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: 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 |
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 |
| Actual Study Start Date: | November 1, 2012 |
| Estimated Study Completion Date: | March 1, 2020 |
| Primary Completion Date: | April 20, 2017 (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
Information from the National Library of Medicine
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| 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
Information from the National Library of Medicine
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
Show 216 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 ) |
| First Submitted: | October 19, 2012 |
| First Posted: | October 23, 2012 |
| 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 |