A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma

Seagen

Status and phase

Completed

Phase 2

Conditions

Disease, Hodgkin

Treatments

Drug: brentuximab vedotin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00848926

2008-006034-10 (EudraCT Number)

SG035-0003

Details and patient eligibility

About

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.

Enrollment

102 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.