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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: February 21, 2017
Last verified: June 2016
June 6, 2013
February 21, 2017
June 2013
December 2015   (Final data collection date for primary outcome measure)
  • Complete Remission Rate [ Time Frame: Up to 16 cycles plus 30 days; approximately 12 months ]
    Complete remission rate among all subjects (Phase 1 and 2 combined) treated at the dose level selected for Phase 2. Complete remission (CR) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma is a disappearance of all evidence of disease.
  • Incidence of Adverse Events [ Time Frame: Up to 16 cycles plus 30 days; approximately 12 months ]
    All AEs reported after initiation of treatment and pre-existing conditions that worsen after initiation of treatment will be considered treatment-emergent AEs (TEAEs). All AEs will be coded by system organ class, MedDRA preferred term, and severity grade using NCI CTCAE V4.03. All recorded AEs will be included in the data listings.
Complete Remission Rate [ Time Frame: Through 1 month following last dose ]
Complete list of historical versions of study NCT01874054 on ClinicalTrials.gov Archive Site
  • Incidence of Dose-limiting Toxicities [ Time Frame: Up to 3 weeks; the first cycle of therapy through the first day of Cycle 2. ]
    Incidence of dose-limiting toxicity (DLT) was evaluated in an initial safety cohort of 10 patients who were followed for protocol-defined DLT events until Cycle 2 Day 1.
  • Overall Best Response Rate [ Time Frame: Every 3 months for up to 3 years ]
    Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease), partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites), stable disease (SD, failure to obtain a complete or partial response or progressive disease), or progressive disease (PD, any new lesion or increase by 50% or more of previously involved sites from nadir) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma
  • Duration of Response [ Time Frame: Up to 3 years ]
    The time from first observation of remission to disease progression/relapse or death from any cause, whichever occurs first.
  • Progression-free Survival [ Time Frame: Up to 3 years ]
    The time from first dose of study medication to first documentation of disease progression/relapse, or to death due to any cause, whichever occurs first.
  • Incidence of adverse events [ Time Frame: Through 1 month following last dose ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ]
  • Incidence of Dose-limiting Toxicities [ Time Frame: Through 1 month following last dose ]
  • Objective response rate [ Time Frame: Through 1 month following last dose ]
  • Duration of Response [ Time Frame: Participants will be followed for an average of 2 years ]
  • Progression-free Survival [ Time Frame: Participants will be followed for an average of 2 years ]
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
Intervention Model: Single Group Assignment
Masking: No masking
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 1.8 mg/kg every 3 weeks for up to 16 cycles by IV infusion and bendamustine 90 mg/m2 on Days 1 and 2 every 3 weeks by IV infusion for up to 6 cycles
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.
 
Active, not recruiting
55
December 2017
December 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01874054
SGN35-016
No
Not Provided
Not Provided
Not Provided
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Not Provided
Study Director: Neil Josephson, MD Seattle Genetics, Inc.
Seattle Genetics, Inc.
June 2016

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