A Phase 1 Study of Brentuximab Vedotin Given Sequentially and Combined With Multi-Agent Chemotherapy for CD30-Positive Mature T-Cell and NK-Cell Neoplasms

Seagen

Status and phase: Completed; Phase 1

Conditions: Lymphoma, Large-Cell, Anaplastic; Lymphoma, T-cell; Lymphoma, NK-cell

Treatments: Drug: vincristine; Drug: cyclophosphamide; Drug: brentuximab vedotin; Drug: doxorubicin; Drug: prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01309789

SGN35-011

2010-022839-11

Details and patient eligibility

About

The purpose of this study is to assess the safety profile of brentuximab vedotin sequentially and in combination with multi-agent chemotherapy in front-line treatment for CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma. It is a phase 1, open-label, dose escalation study in three arms designed to define the MTD, PK, immunogenicity, and anti-tumor activity of brentuximab vedotin in sequence and in combination with multi-agent front-line chemotherapy.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment-naive CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma
• Measurable disease of at least 1.5 cm
• ECOG performance status less than or equal to 2

Exclusion criteria

• Known cerebral/meningeal disease, including history of progressive multifocal leukoencephalopathy
• Current diagnosis of primary cutaneous anaplastic large cell lymphoma, mycosis fungoides, Sezary syndrome or other primary cutaneous lymphomas; extranodal NK/T-cell lymphoma, nasal type
• History of another primary malignancy that has not been in remission for at least 3 years
• Left ventricular ejection fraction <45% or symptomatic cardiac disease, or myocardial infarction within the past 12 months
• Viral, bacterial, or fungal infection within two weeks prior to the first dose of brentuximab vedotin
• Known human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus positive status

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 3 patient groups

1

Experimental group

Description:

Sequential

Treatment:

Drug: prednisone

Drug: doxorubicin

Drug: doxorubicin

Drug: brentuximab vedotin

Drug: prednisone

Drug: cyclophosphamide

Drug: brentuximab vedotin

Drug: vincristine

Drug: cyclophosphamide

2

Experimental group

Description:

Combination

Treatment:

Drug: prednisone

Drug: doxorubicin

Drug: doxorubicin

Drug: brentuximab vedotin

Drug: prednisone

Drug: cyclophosphamide

Drug: brentuximab vedotin

Drug: cyclophosphamide

3 Brentuximab vedotin/CH-P

Experimental group

Description:

Combination

Treatment:

Drug: prednisone

Drug: doxorubicin

Drug: doxorubicin

Drug: brentuximab vedotin

Drug: prednisone

Drug: cyclophosphamide

Drug: brentuximab vedotin

Drug: cyclophosphamide