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

This study is currently recruiting participants.
Verified March 2014 by Seattle Genetics, Inc.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01716806
First received: October 16, 2012
Last updated: March 27, 2014
Last verified: March 2014
  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) in front-line therapy of HL in adults age 60 and above.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Complete remission rate (CR) [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Participants will be followed for an average of 2 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Participants will be followed for an average of 2 years ] [ Designated as safety issue: No ]
  • B symptom resolution rate [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
  • 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: pre-dose, 30 minutes, and 1 month post last dose ] [ Designated as safety issue: No ]
  • Incidence of antitherapeutic antibodies (ATA) [ Time Frame: Cycles 1, 2, 4, and every 4 cycles thereafter: predose, and 1 month post last dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2015 (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: BrentuximabVedotin + 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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716806

Contacts
Contact: Terri Lowe 866-333-7436 clinicaltrials@seagen.com

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294-3300
Contact: Stephanie Biggers    205-975-2944    sbiggers@uab.edu   
Principal Investigator: Andres Forero-Torres, MD         
United States, Arizona
Arizona Oncology Associates, PC - HOPE Recruiting
Tucson, Arizona, United States, 85704
Contact: Marrae McWilliams    520-877-9096    marrae.mcwilliams@usoncology.com   
Principal Investigator: Donald Brooks, M.D.         
United States, California
Providence St Joseph Medical Center Recruiting
Burbank, California, United States, 91505
Contact: Donna Fernando    818-748-4770    donna.fernando@providence.org   
Principal Investigator: Gregg Olsen, M.D.         
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Christine McCarthy    626-256-4673 ext 63811    cmccarthy@coh.org   
Principal Investigator: Robert Chen, M.D.         
Wilshire Oncology Medical Group Inc. Recruiting
Pomona, California, United States, 91767
Contact: Sarah Ortiz    909-596-5333    Sarah.Ortiz@usoncology.com   
Principal Investigator: Swapnil P. Rajurkar, MDM.D.         
United States, Colorado
Rocky Mountain Cancer Centers - Aurora Recruiting
Aurora, Colorado, United States, 80012
Contact: Sara Vigen    719-296-6024    sara.vigen@usoncology.com   
Principal Investigator: John M. Burke, M.D.         
United States, Florida
Florida Cancer Affiliates Recruiting
New Port Richey, Florida, United States, 34655
Contact: Kelly Bretz    727-569-4135    Kelly.Bretz@USOncology.com   
Principal Investigator: Uday Dandamudi, M.D.         
United States, Georgia
Georgia Cancer Specialists - Admin Annex Recruiting
Sandy Springs, Georgia, United States, 30341
Contact: Christopher Moore    770-496-9427    Christopher.Moore@gacancer.com   
Principal Investigator: Mansoor Saleh, M.D.         
United States, Illinois
Illinois Cancer Specialists Recruiting
Niles, Illinois, United States, 60714
Contact: Pian Moy    847-827-9060    Pian.Moy@usoncology.com   
Principal Investigator: Leonard Klein, M.D.         
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, M.D.         
United States, Nebraska
Nebraska Cancer Specialists Recruiting
Omaha, Nebraska, United States, 68114
Contact: Faye Park    402-691-6972    fpark@nebraskacancer.com   
Principal Investigator: Ralph J. Hauke -NCS, M.D.         
United States, New York
New York Oncology Hematology, P.C. Recruiting
Albany, New York, United States, 12206
Contact: Kathy DiSisto    518-786-3152 ext 312    Kathy.Disisto@USONCOLOGY.COM   
Principal Investigator: Lawrence Garbo, M.D.         
Columbia University Medical Center Recruiting
New York, New York, United States, 10022
Contact: Celeste Rojas    212-326-5736    CR2393@cumc.columbia.edu   
Principal Investigator: Jennifer Amengual, M.D.         
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 and Research / USOR Recruiting
Eugene, Oregon, United States, 97401
Contact: Betty Goracke Olguin    541-736-3388    betty.gorackeolguin@usoncology.com   
Principal Investigator: Jeff Sharman, M.D.         
United States, Texas
Texas Oncology - Seton Williamson Recruiting
Round Rock, Texas, United States, 78665
Contact: Marlena Griffin    512-421-4142    marlena.griffin@usoncology.com   
Principal Investigator: Vivian Cline-Burkhardt, M.D.         
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, M.D.         
Virginia Commonwealth University Medical Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Jaime Scott    804-628-1909    jscott@vcu.edu   
Principal Investigator: Beata Holkova, M.D.         
Shenandoah Oncology P.C Recruiting
Winchester, Virginia, United States, 22601
Contact: Claudia Phillips    540-662-1108    claudia.phillips@usoncology.com   
Principal Investigator: William A. Houck III, M.D.         
United States, Washington
Northwest Cancer Specialists, P.C. Recruiting
Vancouver, Washington, United States, 98684
Contact: Tamyra Batsch    503-885-5411    tamyra.batsch@usoncology.com   
Principal Investigator: Kathryn Kolibaba, M.D.         
Wenatchee Valley Medical Center Recruiting
Wenatchee, Washington, United States, 98821
Contact: LaDonna Muscatell    509-663-8711 ext 5014    lmuscatell@wvmedical.com   
Principal Investigator: Mitchell Garrison, M.D.         
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Neil Josephson, MD Seattle Genetics, Inc.
  More Information

No publications provided

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: March 27, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 22, 2014