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
Contacts:
Dana-Farber Cancer Institute:
Deborah Doss, 617-632-5672,
ddoss@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