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SCCA Lymphoma Clinical Trials

SGN-35 w/ CHOP for Anaplastic Large Cell Lymphoma
A Phase 1 Study of Brentuximab Vedotin Administered Sequentially and Concurrently With Multi-Agent Chemotherapy as Front-Line Therapy in Patients With Systemic Anaplastic Large Cell Lymphoma
Status Conditions Phase Study ID
Recruiting Anaplastic Large-Cell Lymphoma Phase I NCT01309789
Summary

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.


Investigator
Andrei Shustov, M.D.
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Treatment-naive systemic anaplastic large cell lymphoma
  • Measurable disease of at least 1.5 cm
  • ECOG performance status less than or equal to 2
Exclusions (conditions that would prevent participation in this study)
  • 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
Last Updated
May 23, 2011
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.