gemcitabine in treating patients with recurrent chronic lymphocytic leukemia

Conditions: Leukemia

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of gemcitabine in treating patients who have recurrent chronic lymphocytic leukemia.

objectives: i. determine the rate and duration of complete and partial remission in patients with recurrent b-cell chronic lymphocytic leukemia treated with gemcitabine. ii. assess the toxicities of this regimen in these patients. outline: patients receive gemcitabine iv over 30 minutes on days 1 and 8. treatment repeats every 4 weeks for a minimum of 3 courses. patients achieving clinical complete remission, complete remission, nodular partial remission, or partial remission following 3 courses of therapy, receive 2 additional courses of therapy. patients achieving complete remission or further improvement following the 2 additional courses of therapy, receive another 2 courses of therapy. patients are followed every 3 months until disease progression or relapse. patients achieving complete remission are followed every 6 months for 1 year.

Eligibility criteria:
disease characteristics: diagnosis of b-cell chronic lymphocytic leukemia manifested by all of the following: minimum threshold peripheral lymphocyte count of at least 5,000/mm3 small to medium sized peripheral blood lymphocytes with no greater than 55% prolymphocytes bone marrow aspirate and biopsy containing at least 30% lymphoid cells immunophenotypic and biopsy evaluation of peripheral blood lymphocytes demonstrating monoclonality of b lymphocytes b-cell markers with cd5 antigen (e.g., t-1, t-101) in the absence of other pan t-cell markers (e.g., cd3, cd2) expression of cd19, cd20, and cd23 b cell surface markers b-cell expression of kappa or lambda light chains active disease with at least one of the following criteria: one or more disease related symptoms: at least 10% weight loss within the past 6 months fever greater than 100.5 f for at least 2 weeks without evidence of infection night sweats without evidence of infection evidence of progressive marrow failure as manifested by the development of or worsening of anemia (hemoglobin less than 11.0 g/dl) and/or thrombocytopenia (platelet count less than 100,000/mm3) (i.e., any stage iii or iv disease) autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy massive (i.e., greater than 6 cm below the left costal margin) or progressive splenomegaly (i.e., a greater than 50% increase over two months) massive (i.e., greater than 10 cm in longest diameter) or progressive lymphadenopathy (i.e., a greater than 50% increase over two months) progressive lymphocytosis with an increase of greater than 50% over a 2 month period (unrelated to corticosteroids) or an anticipated doubling time of less than 6 months no marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any criteria for active disease previously treated with at least a fludarabine or cladribine based regimen and a prior alkylating agent with evidence of recurrent or progressive disease patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: not specified hematopoietic: see disease characteristics platelet count at least 75,000/mm3 hepatic: bilirubin no greater than 1.5 times upper limit of normal (uln) sgot no greater than 1.5 times uln (unless due to hemolysis or chronic lymphocytic leukemia) renal: creatinine no greater than 1.5 times uln cardiovascular: no new york heart association class iii or iv heart disease no myocardial infarction within the past month other: no uncontrolled infection hiv negative no other active malignancy not pregnant or nursing negative pregnancy test fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: see disease characteristics at least 4 weeks since prior chemotherapy endocrine therapy: see disease characteristics no concurrent corticosteroids radiotherapy: at least 4 weeks since prior radiotherapy surgery: at least 4 weeks since prior major surgery

Keywords: refractory chronic lymphocytic leukemia b-cell chronic lymphocytic leukemia