Phase I/II clinical trials for relapsed elderly acute leukemia patients: Importance of performance status at re-induction. A single center retrospective experience

6575 Background: Relapsed/refractory acute leukemia patients (pts) have a poor outcome and should be considered for enrollment on clinical trials. Elderly (≥ 60 yr) acute leukemia patients often are excluded from phase I/II cytotoxic agent re-induction chemotherapy trials due to concerns for treatment-related toxicity. Methods: Pts with relapsed/refractory acute leukemia who were enrolled on three consecutive phase I/II clinical trials at University Hospitals of Cleveland were evaluated for outcome data including complete response (CR), serious adverse events, and overall survival (OS). Outcome data was compared for pts age ≥ 60 yr versus < 60 yr. Pts with ECOG Performance Status (PS) 0 to 3 were eligible and there was no age limitation. Results: Between 1994 and 11/2005, 96 acute leukemia pts median age 60 yr (range 19–78) were enrolled: 29 pts received phase I topotecan-etoposide; 31 pts received phase I fludarabine, carboplatin, and topotecan (FCT); and 37 pts received phase II FCT plus thalidomide. In...