Lymphoma, Large-Cell, Anaplastic, Lymphoma, NK-cell, Lymphoma, T-cell
Conditions
Keywords
Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Drug Therapy, Hematologic Diseases, Lymphoma, monomethyl auristatin E, Lymphoma, Large-Cell, Anaplastic, Lymphoma, T-cell, Lymphoma, NK-cell
Brief 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.
Interventions
DRUGbrentuximab vedotin
1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-2 and if response, Cycles 9-16)
DRUGcyclophosphamide
750 mg/m2 IV every 3 weeks (Cycles 3-8)
DRUGprednisone
100 mg daily PO on Days 1-5 every 3 weeks (Cycles 3-8)
DRUGdoxorubicin
50 mg/m2 IV every 3 weeks (Cycles 3-8)
DRUGvincristine
1.4 mg/m2 IV every 3 weeks (Cycles 3-8)
Sponsors
Millennium Pharmaceuticals, Inc.
Seagen Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events and laboratory abnormalities | Through 1 month after last dose |
Secondary
| Measure | Time frame |
|---|---|
| Brentuximab vedotin concentration in blood | Through 1 month after last dose |
| Antitherapeutic antibodies in blood | Through 1 month after last dose |
| Best clinical response | Through 1 month after last dose |
| Progression-free survival | Until disease progression or study closure |
| Overall survival | Every 3 months until death or study closure |
Countries
United Kingdom, United States
Outcome results
None listed