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A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma
Not Recruiting
Trial ID: NCT01421667
Purpose
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) (Part A). 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) (Part B) as well as further evaluate correlation of CD30 expression
and response in DLBCL (Part C).
Official Title
A Phase 2 Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)
Eligibility
Inclusion Criteria:
- Histologically-confirmed NHL (DLBCL only for Parts B and C)
- Relapsed or refractory disease following at least 1 prior systemic therapy
- Measurable disease of at least 1.5 cm as documented by CT
- Eastern Cooperative Oncology Group (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 (for patients
receiving brentuximab vedotin only) or corticosteroids as monotherapy
- Known cerebral/meningeal disease
Intervention(s):
drug: Brentuximab vedotin
drug: rituximab
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061