NCT00947856

A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study

Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab vedotin study.

Detailed description

This is a multicenter, open-label study to evaluate single-agent brentuximab vedotin (SGN-35) treatment in patients who previously participated in a brentuximab vedotin study, including Studies SGN35-005 (NCT01100502), SGN35-007 (NCT01026233), and SGN35-008 (NCT01026415). Patients treated on this study (SGN35-006) could re-enroll on study if eligible. The study consisted of 2 arms, as follows: * Retreatment arm: Patients with CD30-positive hematologic malignancies who experienced a complete remission (CR) or partial remission (PR) with previous brentuximab vedotin treatment on a clinical study and subsequently experienced disease progression or relapse. The purpose of this arm was to assess safety and efficacy of retreatment with brentuximab vedotin. * Extension treatment arm: Patients with either CD30-positive hematologic or nonhematologic malignancies who completed treatment in a prior brentuximab vedotin study without unacceptable toxicity and experienced clinical benefit as assessed by the investigator. The purpose of this arm was to enable patients who participated in certain prior brentuximab vedotin trials to receive extension treatment and to assess patient safety and survival in the extension treatment setting.

Conditions

• Disease, Hodgkin
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
DRUG	brentuximab vedotin	Every 3 weeks by IV infusion (1.2 or 1.8 mg/kg) until disease progression, unacceptable toxicity, or study closure

Timeline

• Start date: 2009-07-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2009-07-28
• Last updated: 2017-02-02
• Results posted: 2014-05-26

Locations

17 sites across 2 countries: United States, France