Phase 1/2 Study of VSLI Plus Rituximab in Patients With Relapsed and/or Refractory NHL

Inclusion Criteria

• •Histologically-confirmed diffuse large B-cell non-Hodgkin's lymphoma (NHL), as defined by the Revised European American Lymphoma/WHO classification. This included: diffuse large B-cell, primary mediastinal large B-cell lymphoma with sclerosis,intravascular large B-cell lymphoma, immunoblastic B-cell lymphoma, T-cell rich B-cell lymphoma or anaplastic large B-cell lymphoma. In the US protocol only, patients who had transformation from an indolent lymphoma and those who had mantle cell lymphoma were eligible.
• •* Confirmation of CD20 expression on lymphoma cells.
• •* Eastern Cooperative Oncology Group (ECOG) ≤2.
• •* One or more prior chemotherapy regimens. Patients who had received prior rituximab therapy as part of an induction chemotherapy regimen or who had a previous response to rituximab as a single agent were eligible.
• •* Measurable disease in at least 1 site, which had not been previously irradiated.
• •Measurable disease was defined as at least 1 bidimensionally measurable lesion with clearly defined margins that were ≥1.5 cm in the largest dimension determined by physical examination or computed tomography (CT) scan.
• •Total bilirubin and serum creatinine ≤2 times the ULN.
• •Absolute neutrophil count (ANC) ≥0.5 × 109/L, and platelets ≥50 × 109/L.
• •18 years of age or older.
• •Women of childbearing potential who were willing to use an acceptable method of contraception throughout the course of the study.
• •Signed and dated informed consent form.