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

NCT ID: NCT01874054

Last Updated: 2019-02-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2018-02-20

Brief Summary

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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.

Detailed Description

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Conditions

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Hodgkin Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

brentuximab vedotin

Intervention Type DRUG

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

bendamustine

Intervention Type DRUG

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

Interventions

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brentuximab vedotin

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

Intervention Type DRUG

bendamustine

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

Intervention Type DRUG

Other Intervention Names

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Adcetris; SGN-35

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seagen Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil Josephson, MD

Role: STUDY_DIRECTOR

Seagen Inc.

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Pacific Hematology Oncology Associates

San Francisco, California, United States

Site Status

Stanford Cancer Center

Stanford, California, United States

Site Status

Oncology Institute of Hope & Innovation, The

Whittier, California, United States

Site Status

Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Mayo Clinic Minnesota

Rochester, Minnesota, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Jewish Hospital, The

Cincinnati, Ohio, United States

Site Status

Case Western Reserve University / University Hospitals Case Medical Center

Cleveland, Ohio, United States

Site Status

Saint Francis Hospital / Bon Secours

Greenville, South Carolina, United States

Site Status

Charles A. Sammons Cancer Center / Baylor University Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

References

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LaCasce AS, Bociek RG, Sawas A, Caimi P, Agura E, Matous J, Ansell SM, Crosswell HE, Islas-Ohlmayer M, Behler C, Cheung E, Forero-Torres A, Vose J, O'Connor OA, Josephson N, Wang Y, Advani R. Brentuximab vedotin plus bendamustine: a highly active first salvage regimen for relapsed or refractory Hodgkin lymphoma. Blood. 2018 Jul 5;132(1):40-48. doi: 10.1182/blood-2017-11-815183. Epub 2018 Apr 27.

Reference Type DERIVED
PMID: 29703778 (View on PubMed)

Other Identifiers

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SGN35-016

Identifier Type: -

Identifier Source: org_study_id

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