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)

Seagen

Status and phase: Completed; Phase 3

Conditions: Disease, Hodgkin

Treatments: Drug: placebo; Drug: brentuximab vedotin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01100502

SGN35-005

2009-016947-20 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 329 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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329 participants in 2 patient groups, including a placebo group

Brentuximab vedotin

Experimental group

Description:

brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion

Treatment:

Drug: brentuximab vedotin

Placebo

Placebo Comparator group

Description:

placebo every 3 weeks by IV infusion

Treatment:

Drug: placebo