rituximab in pretreated elderly or unfit b-cll patients

Conditions: B-Cell Chronic Lymphocytic Leukemia

Summary: the study will test the efficacy rituximab in addition to glucocorticoids for the treatment of b-cll in elderly or unfit patients.

patient population: pretreated patients with symptomatic b-cll 18-64 years of age with poor performance status or \>/=65 years of age with any performance status. treatment: up-to 4 cycles of glucocorticoid (methylprednisolone or dexamethasone) and rituximab every 21 day. study duration: the study period for each subject is expected to be 21 months. subjects will receive up-to 4 cycles of iv infusion of rituximab and glucocorticoid. maximum duration of treatment is expected to be 6 months. subjects will complete scheduled visits not later than study month 21, thereafter they will enter into the long-term follow-up period. subjects will be followed every 3 months for disease progression, initiation of subsequent leukemia treatment or survival.

Eligibility criteria:
inclusion criteria: * the diagnosis of cd20 positive chronic b lymphocytic leukemia (bcll) confirmed by biopsy or flow-cytometry. * previously treated patients with stage rai i-iv and progressive disease (according to iwcll 2008 guidelines). active b-cll is defined by at least one of the following: at least one of the disease related symptoms: * constitutional symptoms: * weight loss \>10% within the previous 6 months; * fatigue (e.g., who performance status \>/=2); * fever \>/=38c \>/=2 weeks without evidence of infection; * night sweats for more than 1 month without evidence of infection. * evidence of progressive marrow failure as manifested by development of, or worsening of, anemia and/or thrombocytopenia * autoimmune hemolysis and/or thrombocytopenia poorly responsive to corticosteroid therapy. * massive (i.e., \>/=6 cm bellow left costal margin) or progressive or symptomatic splenomegaly. * massive lymphadenopathy or conglomerates (i.e., \>/=10 cm in largest diameter) or progressive or symptomatic lymphadenopathy. * progressive lymphocytosis with an increase \>50% over a 2-month period or an anticipated doubling time of less than 6 months. in patients with initial blood lymphocyte counts of less than 30x10\^9/l ldt should not be used as a single parameter to define treatment indication. marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for protocol therapy. * either of the following: * 18 years of age or older with impaired performance status (cirs \> 6) and /or * 65 years of age or older with any performance status. * signed informed consent form. exclusion criteria: * intolerance to exogenous protein or known severe reaction to the administration of rituximab. * active infection. * cancer radiotherapy, biological therapy or chemotherapy within 3 weeks prior to study day 1. * tbc or fungal infection within the past 6 months even if adequately controlled by treatment. * severe organ deficiency preventing the participation in the study. * major surgery, other than diagnostic surgery, within 4 weeks prior to study day 1. * active peptic ulcer. * inadequately controlled diabetes mellitus. * suspected or confirmed b-cll cns disease. * known to be hiv positive. * difficult to control, uncooperative patients. * allergic disorders in need of chronic glucocorticoid therapy. * other oncological diseases requiring active treatment (except hormonal therapy). * pregnancy and breastfeeding. * patients of reproductive potential who are not using effective methods of contraception.

Keywords: chronic lymphocytic leukemia, relapsed, elderly or unfit patients, methylprednisolone, rituximab