NCT00848926

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

Official Title:

A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

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.

Eligibility

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.

Disease(s) and\or Condition(s)

Disease, Hodgkin

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: brentuximab vedotin
    • Description: 1.8 mg/kg every 3 weeks by intravenous infusion
    • Arm Group Labels: Brentuximab vedotin
Sponsor
  • Seagen Inc.