A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)
Basic Trial Information
|Phase III||Treatment||Closed||18 and over||Pharmaceutical / Industry||SGN35-005|
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).
- 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
- 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
Trial Contact Information
Trial Lead Organizations/Sponsors
Seattle Genetics, Incorporated
- Millennium Pharmaceuticals, Incorporated
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01100502
ClinicalTrials.gov processed this data on March 23, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.