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

Seagen

Status and phase: Completed; Phase 1

Conditions: Disease, Hodgkin

Treatments: Drug: bleomycin; Drug: doxorubicin; Drug: dacarbazine; Drug: brentuximab vedotin; Drug: vinblastine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01060904

SGN35-009

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: vinblastine

Drug: bleomycin

Drug: brentuximab vedotin

Drug: brentuximab vedotin

Drug: dacarbazine

Drug: doxorubicin

2

Experimental group

Description:

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

Treatment:

Drug: vinblastine

Drug: brentuximab vedotin

Drug: brentuximab vedotin

Drug: dacarbazine

Drug: doxorubicin