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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)


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hodgkin Disease

Thank you

Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete remission rate

Outcome Time Frame:

Through 1 month following last dose

Safety Issue:

No

Principal Investigator

Megan O'Meara, MD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SGN35-016

NCT ID:

NCT01874054

Start Date:

June 2013

Completion Date:

December 2017

Related Keywords:

  • Hodgkin Disease
  • Antibody-Drug Conjugate
  • Antibodies, Monoclonal
  • Hodgkin Disease
  • Hematologic Diseases
  • Drug Therapy
  • Immunotherapy
  • Antigens, CD30
  • Lymphoma
  • monomethylauristatin E
  • Hodgkin Disease
  • Lymphoma

Name

Location

Mayo ClinicRochester, Minnesota  55905
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Stanford Cancer CenterStanford, California  94305-5824
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Pacific Hematology Oncology AssociatesSan Francisco, California  94115
Columbia University Medical CenterNew York, New York  10032
University Hospitals Case Medical CenterCleveland, Ohio  44106
Saint Francis HospitalGreenville, South Carolina  29601
Colorado Blood Cancer InstituteDenver, Colorado  80218
Virginia Commonwealth University Medical CenterRichmond, Virginia  23298
Oncology Institute of Hope & Innovation, TheWhittier, California  90603