A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma

Seagen

Status and phase

Completed

Phase 2

Conditions

Lymphoma, Large-Cell, Anaplastic

Lymphoma, Non-Hodgkin

Treatments

Drug: brentuximab vedotin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00866047

SG035-0004

2008-006035-12 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

58 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with relapsed or refractory systemic ALCL who have previously received front line chemotherapy.
Documented anaplastic lymphoma kinase (ALK) status.
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 and measurable disease of at least 1.5 cm as documented by both positron emission tomography and spiral computed tomography.
Received any previous autologous stem cell transplant at least 12 weeks (3 months) prior.
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.
Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible).
Known cerebral/meningeal disease.