Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma

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:
NCT01874054
First received: June 6, 2013
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to assess safety and efficacy of brentuximab vedotin in combination with bendamustine in patients with relapsed or refractory Hodgkin lymphoma. It is an open-label, 2-stage study designed to determine the recommended dose level of bendamustine in combination with brentuximab vedotin. The study will assess the safety profile of the combination treatment and determine what proportion of patients achieve a complete remission.


Condition Intervention Phase
Hodgkin Disease
Drug: brentuximab vedotin
Drug: bendamustine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2 Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Brentuximab Vedotin in Combination With Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Complete remission 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 ]
  • Incidence of dose-limiting toxicities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Objective response rate [ 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 ]

Estimated Enrollment: 50
Study Start Date: June 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brentuximan Vedotin + Bendamustine
Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine
Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous (IV) infusion
Other Name: Adcetris; SGN-35
Drug: bendamustine
90 mg/m2 on Days 1 and 2 of 3-week cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histopathological diagnosis of classical Hodgkin lymphoma
  • Failed standard front-line therapy
  • Measurable disease of at least 1.5 cm as documented by radiographic technique
  • Eastern Cooperative Oncology Group performance status less than or equal to 2

Exclusion Criteria:

  • Received prior salvage therapy, including radiotherapy
  • Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
  • Concurrent use of other investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01874054

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: Aparna Tamhane    205-996-2782    aparna@uab.edu   
Principal Investigator: Andres Forero-Torres, MD         
United States, California
Pacific Hematology Oncology Associates Recruiting
San Francisco, California, United States, 94115
Contact: Joni Beemsterboer    415-600-3967    beemstj@cpmcri.org   
Principal Investigator: Caroline Behler, M.D.         
Stanford Cancer Center Recruiting
Stanford, California, United States, 94305-5821
Contact: Sarah Daadi    650-723-6498    sedaadi@stanford.edu   
Principal Investigator: Ranjana Advani, MD         
Oncology Institute of Hope & Innovation, The Recruiting
Whittier, California, United States, 90603
Contact: Saoul Malcolm    562-693-4477    smalcolm@icrinstitute.com   
Principal Investigator: Eric Cheung         
United States, Colorado
Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States, 80218
Contact: Katy Sandoval    720-754-4894    Katy.Sandoval@HealthONEcares.com   
Principal Investigator: Jeffrey Matous, MD         
United States, Illinois
Cardinal Bernadin Cancer Center / Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Karen Fahey    708-327-3228    kfahey@lumc.edu   
Principal Investigator: Scott Smith, M.D.         
United States, Indiana
St. Francis Medical Group Oncology & Hematology Specialists Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Terri Lowe    866-333-7436    clinicaltrials@seagen.com   
Principal Investigator: Stephen Eric Rubenstein, MD         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Leslie Cowen    617-582-7292    LeslieF_Cowen@dfci.harvard.edu   
Principal Investigator: Ann LaCasce, MD         
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Emilija Mitrikeska    734-647-8901      
Principal Investigator: Mark Kaminski, M.D.         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mayo Clinic Clinical Trials ReferralOffice    507-538-7623      
Principal Investigator: Stephen Ansell, M.D. Ph.D         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-7680
Contact: Maribeth Hohenstein    402-559-9053    mahohens@unmc.edu   
Principal Investigator: Robert Bociek, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Celeste Rojas    212-326-5736    CR2393@cumc.columbia.edu   
Principal Investigator: Ahmed Sawas, M.D.         
United States, Ohio
Jewish Hospital, The Recruiting
Cincinnati, Ohio, United States, 45236
Contact: Chris Hensley    513-686-3385    mchensley@health-partners.org   
Principal Investigator: Miguel Islas-Ohlmayer, MD         
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Nancy Horvath    216-286-2292    nancy.horvath@uhhospitals.org   
Principal Investigator: Paolo Caimi, M.D.         
United States, South Carolina
St. Francis Hospital Recruiting
Greenville, South Carolina, United States, 29601
Contact: Kristina Stoeppler-Biege    864-255-1517    kristina_stoeppler-biege@bshsi.org   
Principal Investigator: Gary Spitzer, M.D.         
United States, Texas
Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Erica Goetz    214-818-8325    erica.goetz@baylorhealth.edu   
Principal Investigator: Edward Agura, M.D.         
United States, Virginia
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.         
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: NCT01874054     History of Changes
Other Study ID Numbers: SGN35-016
Study First Received: June 6, 2013
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 17, 2014