Abstract
This phase II trial investigated rituximab and cladribine in chronic lymphocytic leukemia. Four induction cycles, comprising cladribine (0.1 mg/kg/day days 1–5, cycles 1–4) and rituximab (375 mg/m2 day 1, cycles 2–4), were given every 28 days. Stem cell mobilization (rituximab 375 mg/m2 days 1 and 8; cyclophosphamide 4 g/m2 day 2; and granulocyte colony-stimulating factor 10 µg/kg/day, from day 4) was performed in responders. Of 42 patients, nine achieved complete remission (CR), 15 very good partial remission, and two nodular partial remission (overall response rate 62%). Stem cell mobilization and harvesting (≥2×106 stem cells/kg body weight) were successful in 12 of 20 patients. Rituximab infusion-related adverse events were moderate. The main grade 3/4 adverse events during induction were neutropenia and lymphocytopenia. Rituximab plus cladribine was effective; however, the CR rate was modest and stem cell harvest was impaired in a large number of responding patients.
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