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)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01100502
• Date of registration: 06/04/2010
• Primary sponsor: Seattle Genetics, Inc.
• Public title: 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)
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma Following Autologous Stem Cell Transplant
• Date of first enrolment: April 2010
• Target sample size: 329
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01100502
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Poland, Romania, Russian Federation, Serbia, Spain, United Kingdom, United States

Contacts

• Name: Naomi Hunder, MD
• Affiliation: Seattle Genetics, Inc.

Key inclusion & exclusion 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

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Disease, Hodgkin

Intervention(s)

Drug: brentuximab vedotin

Drug: placebo

Primary Outcome(s)

Progression-free survival [Time Frame: Until disease progression or study closure]

Secondary Outcome(s)

Incidence of adverse events and laboratory abnormalities [Time Frame: Through 1 month following last dose]

Incidence of anti-therapeutic antibodies (ATA) to SGN-35 [Time Frame: Through 1 month following last dose]

Overall survival [Time Frame: Until study closure]

Secondary ID(s)

SGN35-005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Millennium Pharmaceuticals, Inc.