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Research and Clinical Trials

Title  
CALGB 10404: A Randomized Phase II Study of Three Fludarabine/Antibody Combinations for Patients with Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia
Brief Description  
This randomized trial is studying fludarabine and rituximab to compare how well they work with or without lenalidomide or cyclophosphamide in treating patients with symptomatic chronic lymphocytic leukemia.
Who may be Eligible  

Patients must meet the following inclusion criteria to be eligible to enter the study:
  • Diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting the following criteria:
  • Must have symptomatic, active disease and meet 1 of the following risk criteria:
    • Intermediate-risk disease (stage I or II) with evidence of active disease as demonstrated by at least one of the following criteria:
      • Enlarged  spleen, liver and/or lymph nodes
      • Weight loss > 10% within the past 6 months
      • Moderate to severe fatigue
      • Fevers > 100.5° F or night sweats for > 2 weeks without evidence of infection
    • High-risk disease (stage III or IV)
  • Not pregnant or nursing
  • Age > 18  
  • No medical condition requiring chronic use of oral corticosteroids
  • No prior therapy for CLL, including corticosteroids for autoimmune complications that have developed since the initial diagnosis of CLL
Speciality/Disorder  
Leukemia
IRB Number  
09-08-03A
Principal Investigator  
Miller, David

For More Information, Contact  Louise  , Kent
Phone:  (704) 355-7430  Fax:  (704) 355-1188  
Email:  MarieLouise.Kent@carolinas.org
Address:Blumenthal Cancer Center 1025 Morehead Medical Drive Suite 600 Charlotte, NC
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