A RANDOMIZED PHASE-II STUDY ON THE EFFECTS OF 5-AZA-2'-DEOXYCYTIDINE COMBINED WITH EITHER AMSACRINE OR IDARUBICIN IN PATIENTS WITH RELAPSEDACUTE-LEUKEMIA - AN EORTC LEUKEMIA COOPERATIVE GROUP PHASE-II STUDY-(06893)

5-Aza-2'-deoxycytidine combined with either amsacrine or idarubicin ha s been applied in a treatment protocol for patients with a relapse of acute myeloid or lymphocytic leukemia. Sixty-three patients received 5 -Aza-2'-deoxycytidine 125 mg/m(2) as a 6 h infusion every 12 h for 6 d ays in combination with either amsacrine 120 mg/m(2) as a 1 h infusion on days 6 and 7 (n = 30) or idarubicin 12 mg/m(2) as a 15 min infusio n on days 5, 6 and 7 (n = 33). Twenty-three patients (36.5%) obtained a complete remission (CR); eight of 30 patients treated with amsacrine and 15 of 33 treated with idarubicin. Patients with an interval of mo re than 1 year between initial diagnosis and start of the protocol ach ieved CR in 51.4%, compared to 15.4% for patients with an interval of less than 1 year. Patients with normal cytogenetics had a higher CR ra te (61%) than those with abnormal cytogenetic findings (15.8%). Digest ive tract and hematologic toxicity was prolonged, compared to standard induction schedules. Median disease-free survival was approximately 8 months, with only 20% of patients staying in remission for more than 1 year. 5-Aza-2'-deoxycytidine is a good antileukemic agent with consi derable toxicity. Current results merit further investigations in prev iously untreated leukemia.