Welcome To Clinical Connection Our clinical trials database is updated daily Over 250,000 individuals are currently being connected to clinical trials by ClinicalConnection.com!   Trials Alerts Trials Search Health Forum Health News RSS Intro Clinics & Sponsors Member Login	View Clinical Trial (Medical Research Study) A Phase 1/2 Study of TRU-016 in Patients With Previously Treated Chronic Lymphocytic Leukemia - NCT00614042-10021 (Clinical Trial 202317) Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy202317.aspx ** Please review additional "Nearby Studies" on right -----> City:  New York State:   NY Zip Code: 10021 Conditions: Chronic Lymphocytic Leukemia (CLL) Purpose: The purpose of this study is to evaluate the safety and tolerability of TRU-016 in patients with previously treated chronic lymphocytic leukemia. Study summary: This Phase 1/2 open-label study consists of two parts. The initial portion is a Phase 1 dose-escalation study evaluating the safety and tolerability of TRU-016 administered over a 4-week period to patients with relapsed chronic lymphocytic leukemia (CLL). It will identify the MTD and evaluate the pharmacokinetics and immunogenicity of TRU-016. Upon demonstrating satisfactory safety and tolerability in the Phase 1 portion, a Phase 2 expansion cohort may be enrolled to confirm safety and to estimate the clinical benefit of TRU-016. Criteria: Inclusion Criteria: - Diagnosis of chronic lymphocytic lymphoma or small lymphocytic lymphoma - Previous treatment with at least one fludarabine-containing regimen - Demonstrate at least one of the following criteria for active disease requiring treatment: - a)progressive splenomegaly and/or lymphadenopathy; - b)anemia or thrombocytopenia due to bone marrow involvement; - c)unintentional weight loss >10% over preceding 6-month period; - d) NCI Grade 2 or 3 fatigue; - e) fevers >100.5 F or night sweats for > 2 weeks without infection; - f) progressive lymphocytosis with increase of >50% over a 2-month period or anticipated doubling time of < 6 months. - ECOG performance status </= 2 - SGOT, SGPT </= 2.0 x upper limit of normal - ANC >/= 500/uL - Platelets >/= 30,000/uL - Discontinued previous anticancer or investigational therapy for at least 30 days Exclusion Criteria: - Treatment with rituximab within 30 days or alemtuzumab(Campath) within 12 weeks - ANC </= 500/uL - Platelets </= 30,000/mm3 - Previous or concurrent additional malignancy - Significant concurrent medical diseases or conditions - Hepatitis B surface antigen positive - Pregnant or breastfeeding Study is available at: For additional information regarding sites for this trial call 919-319-9374 New York, NY 10021 United States Primary Contact: Janine Koucheki Email: jkoucheki@procro.com Phone: 919-319-9374 If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov. Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account. Data Source: ClinicalTrials.gov Date Processed: November 16, 2009 Modifications to this listing: Only selected fields are shown, please use the link above to view all information about this clinical trial.                 Clinical trials are medical research studies designed to test the safety and/or effectiveness of new drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.	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