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A Phase 1/2 Study of TRU-016 in Patients With Previously Treated Chronic Lymphocytic Leukemia - NCT00614042-43210(Clinical Trial 202318)



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City:  Columbus
State:  
OH
Zip Code: 43210
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
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Data Source: ClinicalTrials.gov
Date Processed: May 21, 2010
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