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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01874054
First received: June 6, 2013
Last updated: November 18, 2014
Last verified: November 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 ]

Enrollment: 55
Study Start Date: June 2013
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 + 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

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Pacific Hematology Oncology Associates
San Francisco, California, United States, 94115
Stanford Cancer Center
Stanford, California, United States, 94305
Oncology Institute of Hope & Innovation, The
Whittier, California, United States, 90603
United States, Colorado
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
United States, Illinois
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Indiana
St. Francis Medical Group Oncology & Hematology Specialists
Indianapolis, Indiana, United States, 46237
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, New York
Columbia University Medical Center
New York, New York, United States, 10022
United States, Ohio
Jewish Hospital, The
Cincinnati, Ohio, United States, 45236
Case Western Reserve University / University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, South Carolina
Medical University of South Carolina/Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Saint Francis Hospital / Bon Secours
Greenville, South Carolina, United States, 29601
United States, Texas
Charles A. Sammons Cancer Center / Baylor University Medical Center
Dallas, Texas, United States, 75246
United States, Virginia
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
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: November 18, 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 November 27, 2014