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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
Status Conditions Phase Study ID
Pending Chronic Lymphocytic Leukemia Phase I FH 2631
NCT01644253
Summary

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).


Investigator
John M. Pagel, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
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 Updated
November 07, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • 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.