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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 20, 2014
Last verified: October 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: Brentuximab 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
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: 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
Contact: Kinley Hurst    205-975-9481    mkhurst@uab.edu   
Principal Investigator: Andres Forero-Torres, MD         
United States, California
Pacific Hematology Oncology Associates Recruiting
San Francisco, California, United States, 94115
Contact: Madeline Decker    415-600-3613    deckerm@cpmcri.org   
Principal Investigator: Caroline Behler, MD         
Stanford Cancer Center Recruiting
Stanford, California, United States, 94305
Contact: Sipra Choudhury    650-723-6498    schoudhury@stanford.edu   
Principal Investigator: Ranjana Advani, MD         
Oncology Institute of Hope & Innovation, The Recruiting
Whittier, California, United States, 90603
Contact: Kirsten Bettino    562-693-4477    kbettino@airesearch.us   
Principal Investigator: Eric Cheung, MD         
United States, Colorado
Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States, 80218
Contact: Nicole Stephens    720-754-4891    Nicole.Stephens@healthonecares.com   
Principal Investigator: Jeffrey Matous, MD         
United States, Illinois
Cardinal Bernardin 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, MD         
United States, Indiana
St. Francis Medical Group Oncology & Hematology Specialists Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Reba Baker    317-859-5252    reba.baker@franciscanalliance.org   
Principal Investigator: Stephen Rubenstein, MD         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Leslie Cowen    617-632-6840    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: Ryan McKendree    734-936-5310    mckendre@med.umich.edu   
Principal Investigator: Mark Kaminski, MD         
United States, Minnesota
Mayo Clinic Minnesota Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mayo Clinic Clinical Trials Referral Office    507-538-7623    ansell.stephen@mayo.edu   
Principal Investigator: Stephen Ansell, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, United States
Contact: Maribeth Hohenstein    402-559-5166    mahohens@unmc.edu   
Principal Investigator: Greg Bociek, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10022
Contact: Celeste Rojas    212-263-4415    cr2393@columbia.edu   
Principal Investigator: Ahmed Sawas, MD         
United States, Ohio
Jewish Hospital, The Recruiting
Cincinnati, Ohio, United States, 45236
Contact: Linda Hinds    513-686-3365    lmhinds@health-partners.org   
Principal Investigator: Miguel Islas-Ohlmayer, MD         
Case Western Reserve University / University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Donna Kane    216-844-8573    donna.kane1@uhhospitals.org   
Principal Investigator: Paolo Caimi, MD         
United States, South Carolina
Medical University of South Carolina/Hollings Cancer Center Recruiting
Charleston, South Carolina, United States, 29425
Contact: Amanda Cameron    843-792-4271    cameroa@musc.edu   
Principal Investigator: Robert Stuart, MD         
Saint Francis Hospital / Bon Secours Recruiting
Greenville, South Carolina, United States, 29601
Contact: Lisa Leary    864-255-1517    lisa_leary@bshsi.org   
Principal Investigator: Howland Crosswell, MD         
United States, Texas
Charles A. Sammons Cancer Center / Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Erica Goetz    214-818-8325    erica.goetz@baylorhealth.edu   
Principal Investigator: Edward Agura, MD         
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, MD         
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: October 20, 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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Antibodies, Monoclonal
Bendamustine
Nitrogen Mustard Compounds
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014