A Study of Brentuximab Vedotin in Relapsed or Refractory CD30-positive Non-Hodgkin Lymphoma

Status: Recruiting
Phase: Phase 2
Diagnosis: Non-Hodgkin's Lymphoma
NCT ID: NCT01421667 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-380


This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).


Conducting Institutions:
Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center, Massachusetts General Hospital

Overall PI:
Eric Jacobsen, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Jon Arnason, MD, Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute: Kathleen McDermott, kmcdermott@partners.org
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Histologically-confirmed CD30-positive NHL - Relapsed or refractory disease following at least 1 prior systemic therapy - Measurable disease of at least 1.5 cm as documented by CT - ECOG performance status less than or equal to 2 Exclusion Criteria: - History of another primary invasive malignancy that has not been in remission for at least 3 years - Current diagnosis of systemic or cutaneous anaplastic large cell lymphoma or mycosis fungoides - B cell lymphoma previously treated with only single-agent rituximab or corticosteroids as monotherapy - Known cerebral/meningeal disease
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