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)

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Disease, Hodgkin

Intervention / Treatment
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* Drug: brentuximab vedotin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brentuximab vedotin<br>brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion | Drug: brentuximab vedotin<br>* Every 21 days by IV infusion (1.8 mg/kg)<br>* Other names: Adcetris;|
| Placebo Comparator: Placebo<br>placebo every 3 weeks by IV infusion | Drug: placebo<br>* Every 21 days by IV infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival by Independent Review | Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first | Up to approximately 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Time from date of randomization to date of death due to any cause | Up to approximately 10 years | 
| Incidence of Adverse Events or Laboratory Abnormalities |  | Up to 12 months | 
| Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin |  | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antigens, CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, Disease, Hodgkin, Drug Therapy, Hematologic Diseases, Immunotherapy, Lymphoma, Monomethylauristatin E