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SCCA Lymphoma Clinical Trials

SGN-35 for Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma - Expanded Access (20100989)
A Treatment-Option Study of Brentuximab Vedotin (SGN-35) in Patients With Progression of Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma
Status Conditions Phase Study ID
Closed Hodgkin's LymphomaAnaplastic Large-Cell Lymphoma Expanded Access 20100989
NCT01196208
Summary

The purpose of this study is to provide the option of brentuximab vedotin treatment to patients randomly allocated to placebo treatment in the Phase 3 study SGN35-005 that experienced disease progression of HL. Additionally in the US only, the purpose of this study is to provide access to brentuximab vedotin for patients with relapsed or refractory HL who have previously received an autologous SCT or patients with relapsed or refractory systemic ALCL who have previously failed frontline chemotherapy.

What is Expanded Access? Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial. Read more about expanded access.


Investigator
Andrei Shustov, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Participated in the placebo arm of the SGN35-005 clinical study and experienced disease progression of HL as defined by the SGN35-005 study protocol. Or in the US only: Patients with relapsed or refractory HL who have previously received an autologous SCT or patients with relapsed or refractory systemic ALCL who have previously failed frontline chemotherapy.
  • Completed any previous treatment with radiation, chemotherapy, biologics and/or investigational agents at least 4 weeks prior to the first dose of brentuximab vedotin
Exclusions (conditions that would prevent participation in this study)
  • History of another primary malignancy that has not been in remission for at least 3 years
  • Known cerebral/meningeal disease
  • Peripheral neuropathy of grade 2 or greater
  • Females who are pregnant or lactating
  • Patients who are eligible to participate in other brentuximab vedotin clinical studies
Last Updated
April 09, 2012
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.