fludarabine in treating patients with 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 fludarabine in treating patients who have chronic lymphocytic leukemia that has not been previously treated.

objectives: * determine the overall response rate (complete and partial) in patients with previously untreated b-cell chronic lymphocytic leukemia treated with oral fludarabine. * determine the molecular complete response rate in patients who achieve a clinical or immunophenotypic complete response when treated with this drug. * determine the progression-free and treatment-free survival of patients treated with this drug. * determine the toxicity of this drug in these patients. * determine the baseline incidence of defined genetic abnormalities in patients treated with this drug. * determine the prognostic and predictive significance of defined genetic abnormalities in patients with respect to response to treatment with this drug. * determine the prognostic and predictive significance of immunophenotypic profile of patients with respect to response to treatment with this drug. outline: this is a multicenter study. patients receive oral fludarabine on days 1-5. treatment repeats every 28 days for 6-8 courses in the absence of disease progression or unacceptable toxicity. patients in complete remission after 6 courses do not receive further study therapy. patients are followed at 2 months and then every 4 months for 2 years. projected accrual: a total of 120 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: * confirmed diagnosis of b-cell chronic lymphocytic leukemia (cll) * previously untreated * rai stage i, ii, iii, or iv * requiring systemic therapy * persistent lymphocytosis of greater than 5,000/mm\^3 * morphologically mature lymphocytes * monoclonal b-cell population * cd19/cd5/cd23 positive with kappa or lambda light chain restriction by immunophenotyping * no other lymphoproliferative disorders including prolymphocytic leukemia, mantle cell lymphoma, progression to aggressive b-cell lymphoma, or richter's syndrome * no clinical autoimmune hematologic complication of cll including coomb's-positive hemolytic anemia or immune thrombocytopenia * positive coomb's test allowed if no clinical hemolysis patient characteristics: age * 16 and over performance status * ecog 0-2 life expectancy * at least 6 months hematopoietic * see disease characteristics hepatic * bilirubin no greater than 2 times upper limit of normal (uln) * ast and/or alt no greater than 2 times uln renal * creatinine no greater than 2 times uln other * accessible for treatment and follow-up * no known hiv infection * no active bacterial, viral, or fungal infection requiring systemic antibiotics * no conditions requiring corticosteroid therapy * no history of other malignancies except for the following: * adequately treated nonmelanoma skin cancer * curatively treated carcinoma in situ of the cervix * other solid tumors curatively treated with no evidence of disease within the past 5 years * no other major medical illness that would preclude study * no known hypersensitivity to fludarabine or its components * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for at least 6 months after study prior concurrent therapy: biologic therapy * no concurrent immunotherapy including monoclonal antibody therapy * no concurrent autologous or allogeneic stem cell or bone marrow transplantation chemotherapy * no other concurrent cytotoxic drugs endocrine therapy * no concurrent corticosteroids except inhaled or topical corticosteroids * no concurrent corticosteroids for nausea prophylaxis radiotherapy * no prior radiotherapy affecting more than 25% of bone marrow and/or involving the pelvic area * no concurrent radiotherapy surgery * not specified other * at least 4 weeks since prior investigational agents * no other concurrent investigational agents

Keywords: b-cell chronic lymphocytic leukemia stage i chronic lymphocytic leukemia stage ii chronic lymphocytic leukemia stage iii chronic lymphocytic leukemia stage iv chronic lymphocytic leukemia