Relapsed or refractory B-cell Non Hodgkin's Lymphoma.
Conditions
Interventions
Product Name: TRU-015
Pharmaceutical Form: Intravenous infusion
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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. With 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. Patient with adequate bone marrow function, renal and adequate hepatic function. And Who have recovered 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). Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (or 2, not declining within past 2 weeks). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. Who received previous radioimmunotherapy. Allogeneic hematopoietic stem cell transplant within 6 months before the first dose of test article. Chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents within 4 weeks before the first dose of test article. Major surgery, not related to debulking surgical procedures, within 3 weeks before the first dose of test article. Symptomatic central nervous system (CNS) NHL; a lumbar puncture is not required unless CNS involvement with NHL is clinically suspected. Compromised immune system due to human immunodeficiency virus (HIV), or current or chronic hepatitis B and/or hepatitis C infection (as detected by positive testing for hepatitis B surface antigen [HbsAg] or antibody to hepatitis C virus [anti-HCV], respectively).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and to determine the maximum tolerated dose (MTD), if reached, of TRU 015 in subjects with relapsed or refractory B cell NHL.;Secondary Objective: To characterize the pharmacokinetics (PK) of TRU 015 in subjects with B cell NHL. To characterize the pharmacodynamic (PD) response following TRU 015 treatment in subjects with B cell NHL. To evaluate the immunogenicity of TRU 015 in subjects with B cell NHL. To evaluate the clinical activity of TRU 015 in an expanded cohort of subjects with relapsed, refractory, or persistent follicular B cell NHL. To evaluate the pharmacogenetics (PGt) and the pharmacogenomics (PG) of subjects with B cell NHL receiving TRU 015.(exploratory) ;Primary end point(s): Safety will be described by summary displays (descriptive statistics and graphs). DLT incidence and adverse event incidence will be described by dose level. The frequency of occurrence of overall toxicity will be summarized. The antitumor activity will be evaluated on an exploratory basis and will be summarized using descriptive statistics or graphics. The objective response rate (complete response [CR] + partial response [PR]) among subjects will be summarized using descriptive statistics and estimated using an exact confident interval approach within each stratum and across all strata. Progression-free survival and overall survival will be evaluated using the Kaplan-Meier method. | — |
Countries
Hungary
Outcome results
None listed