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NCT Number: NCT01060904

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

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.

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Key information

Conditions

Disease, Hodgkin Hematologic Diseases Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

British Columbia Cancer Agency - Vancouver Centre, Vancouver, British Columbia, Canada

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 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

Treatment and study plan

Brentuximab Vedotin

Drug

0.6-1.2 mg/kg IV every 2 weeks

Other names: SGN-35

Doxorubicin

Drug

25 mg/m2 IV every 2 weeks

Vinblastine

Drug

6 mg/m2 IV every 2 weeks

Dacarbazine

Drug

375 mg/m2 IV every 2 weeks

Bleomycin

Drug

10 units/m2 IV every 2 weeks

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

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Collaborators

  • Millennium Pharmaceuticals, Inc.

Registry information

Official study title

A Phase 1 Dose-Escalation Safety Study of Brentuximab Vedotin in Combination With Multi-Agent Chemotherapy as Frontline Therapy in Patients With Hodgkin Lymphoma

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 2, 2010
Registry last updated
Dec 18, 2014

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.

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