Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

Status: Recruiting
Phase: Phase 2
Diagnosis: Multiple Myeloma, Leukemia/MDS
NCT ID: NCT01461538 (View complete trial on
DFCI Protocol ID: 11-449


This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital

Overall PI:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Amir Fathi, M.D., Massachusetts General Hospital

Dana-Farber Cancer Institute: Ilene Galinsky, 617-632-3902,
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Histologically-confirmed by central review CD30-positive nonlymphomatous malignancy - Have failed, refused, or have been deemed ineligible for standard therapy - Measurable disease - Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a Karnofsky or Lansky Performance Status score greater than or equal to 70 Exclusion Criteria: - Primary diagnosis of lymphoma or central nervous system (CNS) malignancy - History of another primary invasive malignancy that has not been definitively treated or in remission for at least 3 years - Evidence of active cerebral/meningeal disease
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