SCCA Lymphoma Clinical Trials
|Closed||Anaplastic Large-Cell Lymphoma||Phase I||NCT01309789|
The purpose of this study is to assess the safety profile of brentuximab vedotin (SGN-35) sequentially and in combination with multi-agent chemotherapy in front-line treatment for systemic anaplastic large cell lymphoma. This 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.
Patients must be at least 18 years of age with a confirmed ALCL diagnosis that is either ALK-positive (Stage 3-4) or ALK-negative (all stages). Patients will be treated with a maximum of 16 cycles of the study drug along with other chemotherapy drugs, if applicable. They will be followed very closely with regular blood draws and clinic visits, along with drug infusions and with periodic disease restaging exams and radiology scans.
- Treatment-naive systemic anaplastic large cell lymphoma
- Measurable disease of at least 1.5 cm
- ECOG performance status less than or equal to 2
- Known cerebral/meningeal disease
- Current diagnosis of primary cutaneous anaplastic large cell lymphoma
- 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
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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