NCT00848926
A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma
PHASE2
COMPLETED
NCT00848926
INTERVENTIONAL
A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
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.
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, Hodgkin
- TREATMENT
-
- Type: DRUG
- Name: brentuximab vedotin
- Description: 1.8 mg/kg every 3 weeks by intravenous infusion
- Arm Group Labels: Brentuximab vedotin
- Seagen Inc.