SCCA Lymphoma Clinical Trials
TRU-016 with Rituximab for Previously Untreated Chronic Lymphocytic Leukemia (FH 2631)
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
|Closed||Chronic Lymphocytic Leukemia||Phase I||
The purpose of this study is to evaluate the safety and efficacy of TRU-016 when when administered in combination with rituximab in patients with previously untreated chronic lymphocytic leukemia (CLL).
Eligibility Criteria (must meet the following to participate in this study)
- 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
- Life expectancy > 6 months in opinion of Investigator
- Serum creatinine, total bilirubin, ALT/SGPT
- ANC >/= 800/mm3
- Platelets >/= 30,000/mm3
Exclusions (conditions that would prevent participation in this study)
- Has received treatment with rituximab, alemtuzumab, ofatumumab or any other chemotherapeutic agent for CLL
- 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
Last UpdatedMay 12, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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- Talk to your health care providers first before making decisions about your health care.
- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.