Study Evaluating TRU-015 in B-Cell Non-Hodgkin's Lymphoma
Study Evaluating TRU-015 in B-Cell Non-Hodgkin's Lymphoma
This is a study to evaluate the safety and efficacy of TRU-015 in treatment of B-cell
 Non-Hodgkin's Lymphoma (NHL).

 TRU-015 is also currently being evaluated in multiple clinical studies for the treatment of
 autoimmune disorders. Over 300 patients have received TRU-015 in these studies, and the data
 observed to date support its safety in patients with autoimmune disorders.

 Safety of an escalating dose of 4 weekly infusions of TRU-015 will be evaluated in subjects
 with relapsed NHL (see inclusion criteria for subtypes).

 Once a maximum tolerated dose (MTD) is confirmed or maximum dose to be studied is determined
 to be safe and well tolerated, an expanded cohort of subjects with relapsed follicular NHL
 will be evaluated for efficacy.
Main Inclusion Criteria:

 -  Subjects with CD20-positive, B cell NHL who, after at least 2 prior therapies of
 probable clinical benefit, have relapsed or refractory disease. The following
 histologies may be included*: lymphoplasmacytic lymphoma (formerly known as
 lymphoplasmacytoid lymphoma), splenic marginal zone B cell lymphoma, extranodal
 marginal zone B cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal
 zone B cell lymphoma, follicular lymphoma, mantle cell lymphoma, diffuse large-cell B
 cell lymphoma, and mediastinal large B cell lymphoma. Small lymphocytic lymphoma will
 be included if it is a primary diagnosis and if the lymphoma cells are < 5.0 x 109/L
 (5000/mm3) in the peripheral blood. *Subjects enrolled in the preliminary efficacy
 cohorts must have relapsed, refractory, or persistent follicular lymphoma (persistent
 disease defined as computed tomography (CT) positive for 3 months after last
 treatment), and must not have received anti-CD20 targeted therapy within 3 months of
 receiving the first dose of test article. Subjects may be considered eligible after a
 single therapy of probable clinical benefit, if no further standard effective
 treatment is available in the opinion of the investigator. Prior CD20
 immunophenotyping of tumors to document B cell NHL is acceptable. If such prior
 documentation is not available, then the immunophenotype of the current disease must
 be documented by fine-needle aspirate or biopsy, or by circulating CD20-positive NHL
 cells from peripheral blood before administration of test article.

 -  At least 1 measurable lesion that is 1.5 cm in at least 1 dimension by CT or magnetic
 resonance imaging (MRI), in an area of no prior radiation therapy, or documented
 progression in an area that was previously irradiated.

 -  Recovery to baseline or grade 1 [according to the National Cancer Institute (NCI)
 Common Terminology Criteria for Adverse Events (CTCAE), version 3.0] from all acute
 adverse effects of prior therapies (excluding alopecia).

 Main Exclusion Criteria:

 -  Candidate for potentially curative therapy that is available to the subject, in the
 clinical opinion of the investigator.

 -  Diagnosis of chronic lymphocytic leukemia, Burkitt's lymphoma, primary effusion
 lymphoma, and/or precursor B cell lymphoblastic lymphoma.

 -  Prior treatments: radioimmunotherapy; allogeneic hematopoietic stem cell transplant
 (within 6 months of first dose of study drug); chemotherapy, cancer immunosuppressive
 therapy, growth factors (except erythropoietin), or investigational agents (within 4
 weeks of first dose of study drug); major surgery not related to debulking surgical
 procedures (within 3 weeks of first dose of study drug).