A Phase 1 Study of Brentuximab Vedotin Given Sequentially and Combined With Multi-Agent Chemotherapy for CD30-Positive Mature T-Cell and NK-Cell Neoplasms

June 27, 2017 updated by: Seagen Inc.

A Phase 1 Study of Brentuximab Vedotin Administered Sequentially and Concurrently With Multi-Agent Chemotherapy as Front-Line Therapy in Patients With CD30-Positive Mature T-Cell and NK-Cell Neoplasms, Including Systemic Anaplastic Large Cell Lymphoma

The purpose of this study is to assess the safety profile of brentuximab vedotin sequentially and in combination with multi-agent chemotherapy in front-line treatment for CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma. It is a phase 1, open-label, dose escalation study in three arms designed to define the MTD, PK, immunogenicity, and anti-tumor activity of brentuximab vedotin in sequence and in combination with multi-agent front-line chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 1

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital NHS Foundation Trust
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • UAB Comprehensive Cancer Center
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • Stanford, California, United States, 94305
        • Stanford Cancer Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • St. Francis Hospital
    • Texas
      • Houston, Texas, United States, 77030-4000
        • MD Anderson Cancer Center / University of Texas
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance / University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Treatment-naive CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma
  • Measurable disease of at least 1.5 cm
  • ECOG performance status less than or equal to 2

Exclusion Criteria:

  • Known cerebral/meningeal disease, including history of progressive multifocal leukoencephalopathy
  • Current diagnosis of primary cutaneous anaplastic large cell lymphoma, mycosis fungoides, Sezary syndrome or other primary cutaneous lymphomas; extranodal NK/T-cell lymphoma, nasal type
  • History of another primary malignancy that has not been in remission for at least 3 years
  • Left ventricular ejection fraction <45% or symptomatic cardiac disease, or myocardial infarction within the past 12 months
  • Viral, bacterial, or fungal infection within two weeks prior to the first dose of brentuximab vedotin
  • Known human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus positive status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Sequential
Drug: brentuximab vedotin
1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-2 and if response, Cycles 9-16)
Other Names:
  • SGN-35
Drug: cyclophosphamide
750 mg/m2 IV every 3 weeks (Cycles 3-8)
Drug: brentuximab vedotin
1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-6 and if response, Cycles 7-16)
Other Names:
  • SGN-35
Drug: prednisone
100 mg daily PO on Days 1-5 every 3 weeks (Cycles 3-8)
Drug: cyclophosphamide
750 mg/m2 IV every 3 weeks (Cycles 1-6)
Drug: doxorubicin
50 mg/m2 IV every 3 weeks (Cycles 3-8)
Drug: doxorubicin
50 mg/m2 IV every 3 weeks (Cycles 1-6)
Drug: prednisone
100 mg daily PO on Days 1-5 every 3 weeks (Cycles 1-6)
Drug: vincristine
1.4 mg/m2 IV every 3 weeks (Cycles 3-8)
EXPERIMENTAL: 2
Combination
Drug: brentuximab vedotin
1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-2 and if response, Cycles 9-16)
Other Names:
  • SGN-35
Drug: cyclophosphamide
750 mg/m2 IV every 3 weeks (Cycles 3-8)
Drug: brentuximab vedotin
1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-6 and if response, Cycles 7-16)
Other Names:
  • SGN-35
Drug: prednisone
100 mg daily PO on Days 1-5 every 3 weeks (Cycles 3-8)
Drug: cyclophosphamide
750 mg/m2 IV every 3 weeks (Cycles 1-6)
Drug: doxorubicin
50 mg/m2 IV every 3 weeks (Cycles 3-8)
Drug: doxorubicin
50 mg/m2 IV every 3 weeks (Cycles 1-6)
Drug: prednisone
100 mg daily PO on Days 1-5 every 3 weeks (Cycles 1-6)
EXPERIMENTAL: 3 Brentuximab vedotin/CH-P
Combination
Drug: brentuximab vedotin
1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-2 and if response, Cycles 9-16)
Other Names:
  • SGN-35
Drug: cyclophosphamide
750 mg/m2 IV every 3 weeks (Cycles 3-8)
Drug: brentuximab vedotin
1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-6 and if response, Cycles 7-16)
Other Names:
  • SGN-35
Drug: prednisone
100 mg daily PO on Days 1-5 every 3 weeks (Cycles 3-8)
Drug: cyclophosphamide
750 mg/m2 IV every 3 weeks (Cycles 1-6)
Drug: doxorubicin
50 mg/m2 IV every 3 weeks (Cycles 3-8)
Drug: doxorubicin
50 mg/m2 IV every 3 weeks (Cycles 1-6)
Drug: prednisone
100 mg daily PO on Days 1-5 every 3 weeks (Cycles 1-6)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events and laboratory abnormalities
Time Frame: Through 1 month after last dose
Through 1 month after last dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Brentuximab vedotin concentration in blood
Time Frame: Through 1 month after last dose
Through 1 month after last dose
Antitherapeutic antibodies in blood
Time Frame: Through 1 month after last dose
Through 1 month after last dose
Best clinical response
Time Frame: Through 1 month after last dose
Through 1 month after last dose
Progression-free survival
Time Frame: Until disease progression or study closure
Until disease progression or study closure
Overall survival
Time Frame: Every 3 months until death or study closure
Every 3 months until death or study closure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

  • Study Director: Dana Kennedy, PharmD, BCOP, Seagen Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

February 28, 2017

Study Registration Dates

First Submitted

February 25, 2011

First Submitted That Met QC Criteria

March 4, 2011

First Posted (ESTIMATE)

March 7, 2011

Study Record Updates

Last Update Posted (ACTUAL)

June 28, 2017

Last Update Submitted That Met QC Criteria

June 27, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGN35-011
  • 2010-022839-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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