Phase 1 trial of gemtuzumab ozogamicin in combination with enocitabine and daunorubicin for elderly patients with relapsed or refractory acute myeloid leukemia: Japan Adult Leukemia Study Group (JALSG)-GML208 study. We conducted a phase 1 study of a combination of gemtuzumab ozogamicin (GO) plus conventional chemotherapy in elderly patients (≥ 65 years old) with relapsed or refractory CD33 -positive acute myeloid leukemia (AML). Patients received a standard dose of enocitabine (200 mg/m² × 8 days) and daunorubicin (30 mg/m² × days 1-3) plus an escalating dose of GO (1.5-5 mg/m² on day 4). The dose escalation of GO was done according to a standard 3 + 3 design following a modified Fibonacci sequence. No dose-limiting toxicities were observed in three patients (median age, 71) at level 1 (1.5
. Findings of comprehensive geriatric assessment and comorbidities are considered while selecting therapeutic modalities. AML score may suggest the appropriateness of the use of intensive chemotherapy. When intensive chemotherapy is tolerable, enocitabine or cytarabine + daunorubicin is used as remission induction chemotherapy. Consolidation chemotherapy comprising three courses of cytarabine-based