NCT01100502

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 Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT01100502

Principal Investigator:

Study Type:

INTERVENTIONAL

Official 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

Summary

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).

Eligibility

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

Disease(s) and\or Condition(s)

Disease, Hodgkin

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: brentuximab vedotin
- Description: Every 21 days by IV infusion (1.8 mg/kg)
- Arm Group Labels: Brentuximab vedotin
- Type: DRUG
- Name: placebo
- Description: Every 21 days by IV infusion
- Arm Group Labels: Placebo

Sponsor

Seagen Inc.