Overview

This trial is active, not recruiting.

Condition disease, hodgkin
Treatment brentuximab vedotin
Phase phase 2
Sponsor Seattle Genetics, Inc.
Collaborator Millennium Pharmaceuticals, Inc.
Start date February 2009
End date August 2010
Trial size 102 participants
Trial identifier NCT00848926, 2008-006034-10, SG035-0003

Summary

This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory Hodgkin lymphoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
brentuximab vedotin SGN-35
1.8 mg/kg every 3 weeks by intravenous infusion

Primary Outcomes

Measure
Objective Response Rate by Independent Review Group
time frame: up to 12 months

Secondary Outcomes

Measure
Complete Remission Rate by Independent Review Group
time frame: up to 12 months
Duration of Objective Response by Kaplan-Meier Analysis
time frame: up to 23.5 months
Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis
time frame: up to 23.5 months
Progression-free Survival by Kaplan-Meier Analysis
time frame: up to 23.5 months
Overall Survival
time frame: up to 23.5 months
Adverse Events by Severity, Seriousness, and Relationship to Treatment
time frame: up to 12 months
Hematology Laboratory Abnormalities >/= Grade 3
time frame: up to 12 months
Chemistry Laboratory Abnormalities >/= Grade 3
time frame: up to 12 months
Area Under the Curve
time frame: 3 weeks
Maximum Serum Concentration
time frame: 3 weeks
Time of Maximum Serum Concentration
time frame: 3 weeks

Eligibility Criteria

Male or female participants at least 12 years old.

Inclusion Criteria: - Patients with relapsed or refractory Hodgkin lymphoma who have previously received autologous stem cell transplant. - Histologically confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block. - Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm as documented by spiral computed tomography. - At US sites patients greater than or equal to 12 years of age may be enrolled. At non-US sites patients must be greater than or equal to 18 years of age. Exclusion Criteria: - Previous treatment with brentuximab vedotin. - Previously received an allogeneic transplant. - Congestive heart failure, Class III or IV, by the New York Heart Association criteria. - History of another primary malignancy that has not been in remission for at least 3 years. - Known cerebral/meningeal disease.

Additional Information

Official title A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Seattle Genetics, Inc..