Overview

This trial is active, not recruiting.

Condition hodgkin disease
Treatments brentuximab vedotin, bendamustine
Phase phase 1/phase 2
Target CD30
Sponsor Seattle Genetics, Inc.
Start date June 2013
End date December 2015
Trial size 55 participants
Trial identifier NCT01874054, SGN35-016

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine
brentuximab vedotin Adcetris; SGN-35
1.8 mg/kg every 3 weeks by intravenous (IV) infusion
bendamustine
90 mg/m2 on Days 1 and 2 of 3-week cycles

Primary Outcomes

Measure
Complete remission rate
time frame: Through 1 month following last dose

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Seattle Genetics, Inc..
Location data was received from the National Cancer Institute and was last updated in June 2016.