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

Trial ID or NCT#

NCT01874054

Status

not recruiting iconNOT RECRUITING

Purpose

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.

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)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

Investigator(s)

Ranjana Advani
Ranjana Advani
Lymphoma specialist, Hematologist-Oncologist
Saul A. Rosenberg, MD, Professor of Lymphoma
Hans-Christoph Becker, MD, FSABI, FSCCT
Radiologist
Clinical Professor, Radiology

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Contact

CCTO
650-498-7061