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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 2, 2014
Last verified: September 2014

June 6, 2013
September 2, 2014
June 2013
June 2015   (final data collection date for primary outcome measure)
Complete remission rate [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01874054 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma
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)

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hodgkin Disease
  • 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
Experimental: Brentuximab Vedotin + Bendamustine
Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine
Interventions:
  • Drug: brentuximab vedotin
  • Drug: bendamustine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2017
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Terri Lowe 866-333-7436 clinicaltrials@seagen.com
United States
 
NCT01874054
SGN35-016
No
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Not Provided
Study Director: Neil Josephson, MD Seattle Genetics, Inc.
Seattle Genetics, Inc.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP