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A Study of Brentuximab Vedotin in Adults Age 60 and Above With Newly Diagnosed Hodgkin Lymphoma (HL)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Seattle Genetics, Inc.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01716806
First received: October 16, 2012
Last updated: May 30, 2017
Last verified: May 2017
  Purpose
This is an open-label, multicenter, phase 2 clinical trial designed to evaluate the efficacy and safety of brentuximab vedotin as a single-agent (Part A) and in combination with dacarbazine (Part B), bendamustine (Part C), or nivolumab (Part D) in front-line therapy of HL in adults age 60 and above.

Condition Intervention Phase
Hodgkin Disease Drug: brentuximab vedotin Drug: bendamustine Drug: dacarbazine Drug: nivolumab Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 2 Open-label Study of Brentuximab Vedotin in Front-line Therapy of Hodgkin Lymphoma (HL) in Adults Age 60 and Above

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: Through 1 month following last dose ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only) ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only) ]
  • Complete remission rate (CR) [ Time Frame: Through 1 month following last dose ]
  • Duration of response [ Time Frame: Participants will be followed for an average of 2 years ]
  • Progression-free survival [ Time Frame: Participants will be followed for an average of 2 years ]
  • B symptom resolution rate [ Time Frame: Through 1 month following last dose ]
  • Blood concentrations of brentuximab vedotin and metabolites [ Time Frame: Cycle 1: predose, 30 minutes, and 24, 48, 168, and 336 hours post-dose; Cycles 2 and later (through 1 month post last dose): pre-dose and 30 minutes ]
  • Incidence of brentuximab vedotin antitherapeutic antibodies (ATA) [ Time Frame: Cycles 1, 2, 4, and every 4 cycles thereafter (through 1 month post last dose [Parts A, B, and C] or through 100 days post last dose of nivolumab [Part D only]): predose ]
  • Blood concentrations of nivolumab and metabolites [ Time Frame: Cycle 1: predose, 30 minutes, and 168 and 336 hours post-dose; Cycles 2, 4, and every 4 cycles thereafter (through 1 month post last dose): pre-dose and 30 minutes ]
  • Incidence of nivolumab antitherapeutic antibodies (ATA) [ Time Frame: Cycles 1, 2, 4, and every 4 cycles thereafter (through 100 days post last dose of nivolumab): predose ]

Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brentuximab Vedotin Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35
Experimental: Brentuximab Vedotin + Dacarbazine Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35
Drug: dacarbazine
375 mg/m2 every 3 weeks by IV infusion
Experimental: Brentuximab Vedotin + Bendamustine Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35
Drug: bendamustine
70 mg/m2 by IV infusion on Days 1 and 2 of 3-week cycle
Experimental: Brentuximab Vedotin + Nivolumab Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35
Drug: nivolumab
3 mg/kg every 3 weeks by IV infusion

  Eligibility

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histopathologically-confirmed diagnosis of classical Hodgkin lymphoma
  • Ineligible for or have declined initial conventional combination chemotherapy
  • Measurable disease of at least 1.5 cm as documented by radiographic technique
  • ECOG performance status less than or equal to 3

Exclusion Criteria:

  • Symptomatic neurologic disease compromising instrumental activities of daily living or requiring medication
  • Concurrent use of other investigational agents
  • Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
  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: NCT01716806

Contacts
Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Melonie Hupp    205-975-2944    mjwest@uabmc.edu   
Principal Investigator: Andres Forero-Torres, MD         
United States, Arizona
Arizona Oncology Associates, PC - HOPE Recruiting
Tucson, Arizona, United States, 85710
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Donald Brooks, MD         
United States, California
Providence St Joseph Medical Center Recruiting
Burbank, California, United States, 91505
Contact: Shelley Norton    818-748-4726    Shelley.Norton@providence.org   
Principal Investigator: Ravi M. Shankar, MD         
United States, Colorado
Rocky Mountain Cancer Centers - Aurora Recruiting
Aurora, Colorado, United States, 80012
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: John Burke, MD         
United States, Florida
Florida Cancer Affiliates Recruiting
Trinity, Florida, United States, 34655
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Fadi E. Nakhl, MD         
United States, Georgia
Georgia Cancer Specialists / Northside Hospital Cancer Institute Recruiting
Sandy Springs, Georgia, United States, 30341
Contact: Duane Stallings    770-496-9400    duane.stallings@gacancer.com   
Principal Investigator: Rodolfo Bordoni, MD         
United States, Illinois
Illinois Cancer Specialists / Advocate Lutheran General Hospital Recruiting
Niles, Illinois, United States, 60714
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Leonard Klein, MD         
United States, Maryland
Center for Cancer and Blood Disorders Recruiting
Bethesda, Maryland, United States, 20817
Contact: Christine DiSilvestre    301-571-2016    cdisilvestre@ccbdmd.com   
Principal Investigator: Ralph Boccia, MD         
United States, Minnesota
Minnesota Oncology Hematology P.A. Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Patrick Flynn, MD         
United States, Nebraska
Nebraska Cancer Specialists Recruiting
Omaha, Nebraska, United States, 68130
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Ralph Hauke, MD         
United States, New York
New York Oncology Hematology, P.C. Recruiting
Albany, New York, United States, 12206
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Lawrence Garbo, MD         
James P. Wilmot Cancer Center / University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Donald Burns    585-273-3903    Don_Burns@URMC.Rochester.edu   
Principal Investigator: Jonathan Friedberg, MD         
United States, Oregon
Willamette Valley Cancer Institute and Research Center Recruiting
Springfield, Oregon, United States, 97477
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Christopher Yasenchak, MD         
Northwest Cancer Specialists, P.C. Recruiting
Tualatin, Oregon, United States, 97062
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Kathryn Kolibaba, MD         
United States, Texas
Texas Oncology - Bedford Recruiting
Bedford, Texas, United States, 76022
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Thomas Anderson, MD         
Texas Oncology - Fort Worth 12th Avenue Recruiting
Fort Worth, Texas, United States, 76104
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Robert L. Ruxer, MD         
Texas Oncology - Longview Recruiting
Longview, Texas, United States, 75601
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Matei Socoteanu, MD         
Texas Oncology - Seton Williamson Recruiting
Round Rock, Texas, United States, 78665
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Vivian Cline-Burkhardt, MD         
United States, Virginia
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care Recruiting
Blacksburg, Virginia, United States, 24060
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Jerome Goldschmidt, MD         
Virginia Cancer Specialists, PC Recruiting
Fairfax, Virginia, United States, 22031
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Dipti Patel-Donnelly, MD         
Virginia Commonwealth University Medical Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Jaime Scott    804-628-1909    jscott@vcu.edu   
Principal Investigator: Beata Holkova, MD         
Shenandoah Oncology P.C. Recruiting
Winchester, Virginia, United States, 22601
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: William Houck III, MD         
Sponsors and Collaborators
Seattle Genetics, Inc.
Bristol-Myers Squibb
Investigators
Study Director: Abraham Fong, MD, PhD Seattle Genetics, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01716806     History of Changes
Other Study ID Numbers: SGN35-015
Study First Received: October 16, 2012
Last Updated: May 30, 2017

Keywords provided by Seattle Genetics, Inc.:
Antibody-Drug Conjugate
Antibodies, Monoclonal
Hematologic Diseases
Hodgkin Disease
Antigens, CD30
Lymphoma
monomethylauristatin E
Drug Therapy

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Antibodies, Monoclonal
Nivolumab
Bendamustine Hydrochloride
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017