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

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Hodgkin's Lymphoma
NCT ID: NCT01874054 (View complete trial on
DFCI Protocol ID: 13-087


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.


Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center

Overall PI:
Ann LaCasce, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Jon Arnason, MD, Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute: Kathleen McDermott,
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility 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
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