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Complete title: A Phase 1b, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of TRU-016 in Combination with Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia
|Research Study Number||2631.00|
|Principal Investigator||John Pagel, MD, PhD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Diagnosis of CLL by IWCLL criteria and with Rai stage intermediate or high risk CLL
- No prior therapy for CLL
- At least one of the following criteria for active disease requiring treatment: progressive splenomegaly and/or lymphadenopathy; anemia or thrombocytopenia due to bone marrow involvement; or progressive lymphocytosis with an increase of >50% over a 2-month period or an unanticipated doubling time of less than 6 months
- Contraindication to chemotherapy as first-line therapy due to patient age, comorbidity or patient preference
- Age >/= to 18 years
- ECOG performance status of </= 2
- Life expectancy > 6 months in opinion of Investigator
- Serum creatinine, total bilirubin, ALT/SGPT </= 2.0 x upper limit of normal
- ANC >/= 800/mm3
- Platelets >/= 30,000/mm3
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Has received an investigational therapy within 30 days of first dose of study drug
- Previous or concurrent additional malignancy
- Clinically significant pulmonary dysfunction, active infection, prior allogeneic bone marrow transplant, active autoimmune disease
- Positive serology for HIV or hepatitis C
- Hepatitis B surface antigen or hepatitis B core antibody positive
- Pregnant or breastfeeding
- Known current drug or alcohol abuse
Other exclusion criteria may apply.
Leukemia; Lymphoma; Lymphoproliferative Disease
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