A Phase 1/2 Study of TRU-016 in Patients With Previously Treated Chronic Lymphocytic Leukemia - NCT00614042-35294 (Clinical Trial 202315)


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A Phase 1/2 Study of TRU-016 in Patients With Previously Treated Chronic Lymphocytic Leukemia - NCT00614042-35294 (Clinical Trial 202315)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy202315.aspx

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City:

Birmingham

State:

Zip Code:

35294

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
Birmingham, AL 35294
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.

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Data Source:

ClinicalTrials.gov

Date Processed:

November 16, 2009

Modifications to
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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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