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

Seagen Inc.55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hodgkin Disease

Interventions

brentuximab vedotinDRUG

1.8 mg/kg every 3 weeks by intravenous (IV) infusion

bendamustineDRUG

90 mg/m2 on Days 1 and 2 of 3-week cycles

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Pacific Hematology Oncology Associates

San Francisco, California, United States

Stanford Cancer Center

Outcomes

Primary Outcomes

Complete Remission Rate

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.

Time frame: Up to 4.6 months

Incidence of Adverse Events (AEs)

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.

Time frame: Up to 13.8 months

Secondary Outcomes

Incidence of Dose-limiting Toxicities

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.

Time frame: Up to 3 weeks; first cycle of therapy through the first day of Cycle 2

Overall Best Response Rate

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

Time frame: Up to 4.6 months

Duration of Response

The time from first observation of remission to disease progression/relapse or death from any cause, whichever occurs first.

Time frame: Up to 47.8 months

Data from ClinicalTrials.gov

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