Skip to main content
OpenTrials
Completed

NCT Number: NCT01309789

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lymphoma, Large-Cell, Anaplastic Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, NK-cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Christie Hospital NHS Foundation Trust, Manchester, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brentuximab Vedotin

Drug

1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-2 and if response, Cycles 9-16)

Other names: SGN-35

Cyclophosphamide

Drug

750 mg/m2 IV every 3 weeks (Cycles 3-8)

Prednisone

Drug

100 mg daily PO on Days 1-5 every 3 weeks (Cycles 3-8)

Doxorubicin

Drug

50 mg/m2 IV every 3 weeks (Cycles 3-8)

Vincristine

Drug

1.4 mg/m2 IV every 3 weeks (Cycles 3-8)

Primary outcomes

  1. Incidence of adverse events and laboratory abnormalities

    Time frame: Through 1 month after last dose

Secondary outcomes

  1. Brentuximab vedotin concentration in blood

    Time frame: Through 1 month after last dose

  2. Antitherapeutic antibodies in blood

    Time frame: Through 1 month after last dose

  3. Best clinical response

    Time frame: Through 1 month after last dose

  4. Progression-free survival

    Time frame: Until disease progression or study closure

  5. Overall survival

    Time frame: Every 3 months until death or study closure

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Collaborators

  • Millennium Pharmaceuticals, Inc.

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2017
First posted
Mar 7, 2011
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.