Overview

This trial is active, not recruiting.

Condition disease, hodgkin
Treatments brentuximab vedotin, placebo
Phase phase 3
Targets CD30, TNF-alpha
Sponsor Seattle Genetics, Inc.
Collaborator Millennium Pharmaceuticals, Inc.
Start date April 2010
End date August 2014
Trial size 329 participants
Trial identifier NCT01100502, SGN35-005

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
brentuximab vedotin
brentuximab vedotin SGN-35
Every 21 days by IV infusion (1.8 mg/kg)
(Active Comparator)
placebo
placebo
Every 21 days by IV infusion

Primary Outcomes

Measure
Progression-free survival
time frame: Until disease progression or study closure

Secondary Outcomes

Measure
Overall survival
time frame: Until study closure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Seattle Genetics, Inc..
Location data was received from the National Cancer Institute and was last updated in April 2016.