Trials / Completed
CompletedNCT01309789
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
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Seagen Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | brentuximab vedotin | 1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-2 and if response, Cycles 9-16) |
| DRUG | cyclophosphamide | 750 mg/m2 IV every 3 weeks (Cycles 3-8) |
| DRUG | brentuximab vedotin | 1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-6 and if response, Cycles 7-16) |
| DRUG | prednisone | 100 mg daily PO on Days 1-5 every 3 weeks (Cycles 3-8) |
| DRUG | cyclophosphamide | 750 mg/m2 IV every 3 weeks (Cycles 1-6) |
| DRUG | doxorubicin | 50 mg/m2 IV every 3 weeks (Cycles 3-8) |
| DRUG | doxorubicin | 50 mg/m2 IV every 3 weeks (Cycles 1-6) |
| DRUG | prednisone | 100 mg daily PO on Days 1-5 every 3 weeks (Cycles 1-6) |
| DRUG | vincristine | 1.4 mg/m2 IV every 3 weeks (Cycles 3-8) |
Timeline
- Start date
- 2011-02-01
- Primary completion
- 2013-04-01
- Completion
- 2017-02-28
- First posted
- 2011-03-07
- Last updated
- 2017-06-28
Locations
11 sites across 2 countries: United States, United Kingdom
Source: ClinicalTrials.gov record NCT01309789. Inclusion in this directory is not an endorsement.