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A Phase 1 Study of Brentuximab Vedotin Combined With Multi-Agent Chemotherapy for Hodgkin Lymphoma

NCT ID: NCT01060904

Last Updated: 2014-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-09-30

Brief Summary

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The purpose of this study is to assess the safety profile of brentuximab vedotin in combination with multi-agent chemotherapy in treatment-naive Stage IIa or IIb-IV Hodgkin lymphoma. It is a phase 1, two-arm, open-label dose escalation study designed to define the maximum tolerated dose, pharmacokinetics, immunogenicity and anti-tumor activity of brentuximab vedotin in combination with frontline therapy.

Detailed Description

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Conditions

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Disease, Hodgkin

Keywords

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Antibodies, Monoclonal Antibody-Drug Conjugate Antigens, CD30 Disease, Hodgkin Hematologic Diseases Immunotherapy Lymphoma monomethyl auristatin E

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine)

Group Type EXPERIMENTAL

brentuximab vedotin

Intervention Type DRUG

0.6-1.2 mg/kg IV every 2 weeks

doxorubicin

Intervention Type DRUG

25 mg/m2 IV every 2 weeks

vinblastine

Intervention Type DRUG

6 mg/m2 IV every 2 weeks

dacarbazine

Intervention Type DRUG

375 mg/m2 IV every 2 weeks

bleomycin

Intervention Type DRUG

10 units/m2 IV every 2 weeks

2

brentuximab vedotin combined with AVD (doxorubicin, vinblastine, dacarbazine)

Group Type EXPERIMENTAL

doxorubicin

Intervention Type DRUG

25 mg/m2 IV every 2 weeks

vinblastine

Intervention Type DRUG

6 mg/m2 IV every 2 weeks

dacarbazine

Intervention Type DRUG

375 mg/m2 IV every 2 weeks

brentuximab vedotin

Intervention Type DRUG

0.9-1.2 mg/kg IV every 2 weeks

Interventions

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brentuximab vedotin

0.6-1.2 mg/kg IV every 2 weeks

Intervention Type DRUG

doxorubicin

25 mg/m2 IV every 2 weeks

Intervention Type DRUG

vinblastine

6 mg/m2 IV every 2 weeks

Intervention Type DRUG

dacarbazine

375 mg/m2 IV every 2 weeks

Intervention Type DRUG

bleomycin

10 units/m2 IV every 2 weeks

Intervention Type DRUG

brentuximab vedotin

0.9-1.2 mg/kg IV every 2 weeks

Intervention Type DRUG

Other Intervention Names

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SGN-35 SGN-35

Eligibility Criteria

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Inclusion Criteria

* Treatment-naive Hodgkin lymphoma, Stage IIa or IIb-IV
* Measurable disease of at least 1.5 cm
* Eastern Cooperative Oncology Group performance status \<3

Exclusion Criteria

* History of another primary malignancy that has not been in remission for at least 3 years
* Known cerebral/meningeal disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

Seagen Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Naomi Hunder, MD

Role: STUDY_DIRECTOR

Seagen Inc.

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

UNC Lineberger Comprehensive Cancer Center / University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

MD Anderson Cancer Center / University of Texas

Houston, Texas, United States

Site Status

British Columbia Cancer Agency - Vancouver Centre

Vancouver, British Columbia, Canada

Site Status

Countries

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United States Canada

References

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Younes A, Connors JM, Park SI, Fanale M, O'Meara MM, Hunder NN, Huebner D, Ansell SM. Brentuximab vedotin combined with ABVD or AVD for patients with newly diagnosed Hodgkin's lymphoma: a phase 1, open-label, dose-escalation study. Lancet Oncol. 2013 Dec;14(13):1348-56. doi: 10.1016/S1470-2045(13)70501-1. Epub 2013 Nov 15.

Reference Type RESULT
PMID: 24239220 (View on PubMed)

Other Identifiers

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SGN35-009

Identifier Type: -

Identifier Source: org_study_id