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..
Location data was received from the National Cancer Institute and was last updated in August 2016.