4-Demethoxydaunorubicin (Idarubicin) in Combination with 1-β-d-Arabinofuranosylcytosine in the Treatment of Relapsed or Refractory Acute Leukemia

摘要: We conducted a Phase I–II trial of 4-demethoxydaunorubicin (idarubicin, IDR) in combination with 1-β-d-arabinofuranosylcytosine (ara-C) 51 patients relapsed or refractory acute nonlymphocytic leukemia, lymphocytic chronic myelogenous leukemia blast crisis. Only 1 12 treated at the first dose level 10 mg/m2/day for 3 days and ara-C, 25 mg/m2 i.v. bolus followed by 200 continuous infusion daily 5 days) achieved aplasia complete remission. The idarubicin was subsequently increased to 4 ara-C held constant. Complete remission incidence this schedule was: 7 31 0 patient crisis, 2 biphenotypic leukemia. Nonhematological toxicity included nausea, vomiting, mucositis, abnormal liver function tests. Detailed pharmacological studies were performed determine whether altered IDR metabolism that its main metabolite, 13-hydroxyidarubicinol clearance. A high degree variability among apparent no consistent effect could be demonstrated. In summary, 9 37 (24%) ANLL, including conclude is an active