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

Information source: Seattle Genetics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Disease, Hodgkin

Intervention: brentuximab vedotin (Drug); doxorubicin (Drug); vinblastine (Drug); dacarbazine (Drug); bleomycin (Drug); brentuximab vedotin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Seattle Genetics, Inc.

Official(s) and/or principal investigator(s):
Naomi Hunder, MD, Study Director, Affiliation: Seattle Genetics, Inc.

Summary

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.

Clinical Details

Official 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of adverse events and laboratory abnormalities

Secondary outcome:

Brentuximab vedotin concentration in blood

Antitherapeutic antibodies in blood

Best clinical response

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

British Columbia Cancer Agency - Vancouver Centre, Vancouver, British Columbia V5Z 4E6, Canada

Mayo Clinic, Rochester, Minnesota 55905, United States

UNC Lineberger Comprehensive Cancer Center / University of North Carolina, Chapel Hill, North Carolina 27599, United States

MD Anderson Cancer Center / University of Texas, Houston, Texas 77030, United States

Additional Information

Starting date: January 2010
Last updated: December 17, 2014

Page last updated: August 23, 2015

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