A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma
Trial ID or NCT#
Status
Purpose
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.
Official Title
A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL)
Eligibility 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.
- * 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.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Peds Hem/Onc CRAs
650-723-5535
View on ClinicalTrials.gov