Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia
Condition: Anemia; Cancer Fatigue; Chronic Lymphocytic Leukemia; Fever; Infectious Disorder; Lymphadenopathy; Lymphocytosis; Night Sweats; Prolymphocytic Leukemia; Recurrent Chronic Lymphocytic Leukemia; Richter Syndrome; Secondary Malignant Neoplasm; Thrombocytopenia; Weight Loss
MeSH terms: Communicable Diseases; Infections; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Prolymphocytic; Thrombocytopenia; Lymphadenopathy; Lymphocytosis; Weight Loss
Intervention: Ex Vivo-activated Autologous Lymph Node Lymphocytes; Laboratory Biomarker Analysis
Intervention description: Given IV; Correlative studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Healthy volunteers: No

Summary:

      This phase II trial studies the side effects of ex vivo-activated autologous lymph node
      lymphocytes infusion and to see how well they work in treating patients with chronic
      lymphocytic leukemia. Biological therapies, such as ex vivo-activated autologous lymph node
      lymphocytes, use substances made from living organisms that may stimulate or suppress the
      immune system in different ways and stop tumor cells from growing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients must have a diagnosis of chronic lymphocytic leukemia (CLL) by
             immunophenotyping and flow cytometry analysis of blood or bone marrow

               -  Patients must meet criteria for treatment based on the criteria proposed by
                  National Cancer Institute (NCI)-sponsored CLL Working Group to include at least
                  one of the following:

                    -  Weight loss of more than 10% over the preceding 6 months; or

                    -  Extreme fatigue attributable to progressive disease; or

                    -  Fever or night sweats without evidence of infection; or

                    -  Worsening anemia (Rai stage Ill) or thrombocytopenia (Rai stage IV); or

                    -  Massive lymphadenopathy (> 10 cm) or rapidly progressive lymphocytosis
                       (lymphocyte doubling time < 6 months); or

                    -  Prolymphocytic or Richter's transformation; or

               -  Patients with CLL who have received at least one prior line of therapy; or

               -  Patients with CLL who have frequent infections and/or recurrent secondary cancers

          -  No active central nervous system (CNS) disease

          -  All patients must have a Karnofsky performance score > 60%

          -  Calculated creatinine clearance (by Cockcroft-Gault) of > 50 ml/min

          -  Patients must not have untreated or uncontrolled life-threatening infection

          -  Patients must sign informed consent

        Exclusion Criteria:

          -  Receipt of glucocorticoids (with the exception of inhaled glucocorticoid steroids for
             the use of allergic rhinitis or pulmonary disease) within 2 weeks of registration

          -  Autoimmune disease related to CLL, e.g., idiopathic thrombocytopenic purpura (ITP) or
             autoimmune hemolytic anemia, is permitted if not requiring active treatment