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

Status:	Active, not recruiting
Conditions:	Lymphoma, Lymphoma
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	12 - Any
Updated:	4/21/2016
Start Date:	March 2009
End Date:	June 2016

A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL)

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.

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.

We found this trial at

sites

Univ of Washington

Seattle, Washington 98104

(206) 543-2100