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

Disease, Hodgkin Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060904
• Other study ID #: SGN35-009
• Status: Completed
• Phase: Phase 1
• First received: January 29, 2010
• Last updated: December 17, 2014
• Start date: January 2010
• Est. completion date: September 2012

Study information

• Verified date: December 2014
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Disease, Hodgkin
• Hodgkin Disease

Intervention

Drug:
• brentuximab vedotin
0.6-1.2 mg/kg IV every 2 weeks
• doxorubicin
25 mg/m2 IV every 2 weeks
• vinblastine
6 mg/m2 IV every 2 weeks
• dacarbazine
375 mg/m2 IV every 2 weeks
• bleomycin
10 units/m2 IV every 2 weeks
• brentuximab vedotin
0.9-1.2 mg/kg IV every 2 weeks

Locations

Country	Name	City	State
Canada	British Columbia Cancer Agency - Vancouver Centre	Vancouver	British Columbia
United States	UNC Lineberger Comprehensive Cancer Center / University of North Carolina	Chapel Hill	North Carolina
United States	MD Anderson Cancer Center / University of Texas	Houston	Texas
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.	Millennium Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events and laboratory abnormalities		Through 1 month after last dose	Yes
Secondary	Brentuximab vedotin concentration in blood		Through 1 month after last dose	No
Secondary	Antitherapeutic antibodies in blood		Through 1 month after last dose	Yes
Secondary	Best clinical response		Through 1 month after last dose	No