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

Sponsor

Seagen Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01060904

Collaborator

Millennium Pharmaceuticals, Inc. (Industry)

Enrollment

Locations

Arms

Duration (Months)

12.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Disease, Hodgkin	Drug: brentuximab vedotin Drug: doxorubicin Drug: vinblastine Drug: dacarbazine Drug: bleomycin Drug: brentuximab vedotin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine)	Drug: brentuximab vedotin 0.6-1.2 mg/kg IV every 2 weeks Other Names: SGN-35 Drug: doxorubicin 25 mg/m2 IV every 2 weeks Drug: vinblastine 6 mg/m2 IV every 2 weeks Drug: dacarbazine 375 mg/m2 IV every 2 weeks Drug: bleomycin 10 units/m2 IV every 2 weeks
Experimental: 2 brentuximab vedotin combined with AVD (doxorubicin, vinblastine, dacarbazine)	Drug: doxorubicin 25 mg/m2 IV every 2 weeks Drug: vinblastine 6 mg/m2 IV every 2 weeks Drug: dacarbazine 375 mg/m2 IV every 2 weeks Drug: brentuximab vedotin 0.9-1.2 mg/kg IV every 2 weeks Other Names: SGN-35

Arm

Intervention/Treatment

Experimental: 1

brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine)

Drug: brentuximab vedotin

0.6-1.2 mg/kg IV every 2 weeks

Other Names:

SGN-35

Drug: doxorubicin

25 mg/m2 IV every 2 weeks

Drug: vinblastine

6 mg/m2 IV every 2 weeks

Drug: dacarbazine

375 mg/m2 IV every 2 weeks

Drug: bleomycin

10 units/m2 IV every 2 weeks

Experimental: 2

brentuximab vedotin combined with AVD (doxorubicin, vinblastine, dacarbazine)

Drug: doxorubicin

25 mg/m2 IV every 2 weeks

Drug: vinblastine

6 mg/m2 IV every 2 weeks

Drug: dacarbazine

375 mg/m2 IV every 2 weeks

Drug: brentuximab vedotin

0.9-1.2 mg/kg IV every 2 weeks

Other Names:

SGN-35

Outcome Measures

Primary Outcome Measures

Incidence of adverse events and laboratory abnormalities [Through 1 month after last dose]

Secondary Outcome Measures

Brentuximab vedotin concentration in blood [Through 1 month after last dose]
Antitherapeutic antibodies in blood [Through 1 month after last dose]
Best clinical response [Through 1 month after last dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905
2	UNC Lineberger Comprehensive Cancer Center / University of North Carolina	Chapel Hill	North Carolina	United States	27599
3	MD Anderson Cancer Center / University of Texas	Houston	Texas	United States	77030
4	British Columbia Cancer Agency - Vancouver Centre	Vancouver	British Columbia	Canada	V5Z 4E6