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SCCA Lymphoma Clinical Trials

SGN-35 for High Risk Residual Hodgkin Lymphoma Post Transplant (FH 2374)
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 (brentuximab vedotin) and Best Supportive Care (BSC) versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin's Lymphoma (HL) Following Autologous Stem Cell Transplant (ASCT)
Status Conditions Phase Study ID
Closed Hodgkin's Lymphoma Phase III FH 2374
NCT01100502
Summary

Purpose: This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).


Investigator
Leona Holmberg, MD, PhD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with HL who have received ASCT in the previous 30-45 days
  • Patients at high risk of residual HL post ASCT
  • Histologically-confirmed HL
  • ECOG of 0 or 1
  • Adequate organ function
Exclusions (conditions that would prevent participation in this study)

 

  • Previous treatment with brentuximab vedotin
  • Previously received an allogeneic transplant
  • Patients who were determined to have a best clinical response of progressive disease with salvage treatment immediately prior to ASCT
  • History of another primary malignancy that has not been in remission for at least 3 years
  • Post ASCT or current therapy with other systemic anti-neoplastic or investigational agents

 

Last Updated
December 21, 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.