Overview

This trial is active, not recruiting.

Conditions lymphoma, large-cell, anaplastic, lymphoma, nk-cell, lymphoma, t-cell
Treatments brentuximab vedotin, cyclophosphamide, prednisone, doxorubicin, vincristine
Phase phase 1
Sponsor Seattle Genetics, Inc.
Collaborator Millennium Pharmaceuticals, Inc.
Start date February 2011
End date April 2013
Trial size 39 participants
Trial identifier NCT01309789, 2010-022839-11, SGN35-011

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Sequential
brentuximab vedotin SGN-35
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)
prednisone
100 mg daily PO on Days 1-5 every 3 weeks (Cycles 3-8)
doxorubicin
50 mg/m2 IV every 3 weeks (Cycles 3-8)
vincristine
1.4 mg/m2 IV every 3 weeks (Cycles 3-8)
(Experimental)
Combination
brentuximab vedotin SGN-35
1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-6 and if response, Cycles 7-16)
cyclophosphamide
750 mg/m2 IV every 3 weeks (Cycles 1-6)
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)
(Experimental)
Combination
brentuximab vedotin SGN-35
1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-6 and if response, Cycles 7-16)
cyclophosphamide
750 mg/m2 IV every 3 weeks (Cycles 1-6)
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)

Primary Outcomes

Measure
Incidence of adverse events and laboratory abnormalities
time frame: Through 1 month after last dose

Secondary Outcomes

Measure
Brentuximab vedotin concentration in blood
time frame: Through 1 month after last dose
Antitherapeutic antibodies in blood
time frame: Through 1 month after last dose
Best clinical response
time frame: Through 1 month after last dose
Progression-free survival
time frame: Until disease progression or study closure
Overall survival
time frame: Every 3 months until death or study closure

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Seattle Genetics, Inc..