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

Seagen Inc.87 sites in 7 countries329 target enrollmentApril 30, 2010

ConditionsDisease, Hodgkin

Interventionsbrentuximab vedotin placebo

Drugsbrentuximab vedotin placebo

Overview

Phase: Phase 3
Intervention: brentuximab vedotin
Conditions: Disease, Hodgkin
Sponsor: Seagen Inc.
Enrollment: 329
Locations: 87
Primary Endpoint: Progression-free Survival by Independent Review
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

April 30, 2010

End Date

April 27, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seagen Inc.

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Brentuximab vedotin

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

Intervention: brentuximab vedotin

Placebo

placebo every 3 weeks by IV infusion

Intervention: placebo

Outcomes

Primary Outcomes

Progression-free Survival by Independent Review

Time Frame: Up to approximately 4 years

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

Secondary Outcomes

Overall Survival(Up to approximately 10 years)
Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin(Up to 12 months)
Incidence of Adverse Events or Laboratory Abnormalities(Up to 12 months)