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

Lymphoma, T-cell Clinical Trial

Official title:

A Phase 1 Study of Brentuximab Vedotin Administered Sequentially and Concurrently With Multi-Agent Chemotherapy as Front-Line Therapy in Patients With CD30-Positive Mature T-Cell and NK-Cell Neoplasms, Including Systemic Anaplastic Large Cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309789
• Other study ID #: SGN35-011
• Secondary ID: 2010-022839-11
• Status: Completed
• Phase: Phase 1
• First received: February 25, 2011
• Last updated: June 27, 2017
• Start date: February 2011
• Est. completion date: February 28, 2017

Study information

• Verified date: June 2017
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 28, 2017
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, NK-cell
• Lymphoma, T-cell
• Neoplasms

Intervention

Drug:
• brentuximab vedotin
1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-2 and if response, Cycles 9-16)
• cyclophosphamide
750 mg/m2 IV every 3 weeks (Cycles 3-8)
• brentuximab vedotin
1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-6 and if response, Cycles 7-16)
• prednisone
100 mg daily PO on Days 1-5 every 3 weeks (Cycles 3-8)
• cyclophosphamide
750 mg/m2 IV every 3 weeks (Cycles 1-6)
• doxorubicin
50 mg/m2 IV every 3 weeks (Cycles 3-8)
• doxorubicin
50 mg/m2 IV every 3 weeks (Cycles 1-6)
• prednisone
100 mg daily PO on Days 1-5 every 3 weeks (Cycles 1-6)
• vincristine
1.4 mg/m2 IV every 3 weeks (Cycles 3-8)

Locations

Country	Name	City	State
United Kingdom	Christie Hospital NHS Foundation Trust	Manchester
United Kingdom	Southampton General Hospital	Southampton
United States	UAB Comprehensive Cancer Center	Birmingham	Alabama
United States	City of Hope National Medical Center	Duarte	California
United States	St. Francis Hospital	Greenville	South Carolina
United States	MD Anderson Cancer Center / University of Texas	Houston	Texas
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Seattle Cancer Care Alliance / University of Washington Medical Center	Seattle	Washington
United States	Stanford Cancer Center	Stanford	California

Sponsors (2)

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

Countries where clinical trial is conducted

United States,  United Kingdom, 

References & Publications (1)

Fanale MA, Horwitz SM, Forero-Torres A, Bartlett NL, Advani RH, Pro B, Chen RW, Davies A, Illidge T, Huebner D, Kennedy DA, Shustov AR. Brentuximab vedotin in the front-line treatment of patients with CD30+ peripheral T-cell lymphomas: results of a phase — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events and laboratory abnormalities		Through 1 month after last dose
Secondary	Brentuximab vedotin concentration in blood		Through 1 month after last dose
Secondary	Antitherapeutic antibodies in blood		Through 1 month after last dose
Secondary	Best clinical response		Through 1 month after last dose
Secondary	Progression-free survival		Until disease progression or study closure
Secondary	Overall survival		Every 3 months until death or study closure