Cladribine combined with high doses of arabinoside cytosine, mitoxantrone, and G‐CSF (CLAG‐M) is a highly effective salvage regimen in patients with refractory and relapsed acute myeloid leukemia of the poor risk: a final report of the Polish Adult Leukemia Group

摘要: Objectives:  Patients with primary refractory AML and early relapses have unfavorable prognoses require innovative therapeutic approaches. Purine analogs fludarabine (FA) cladribine (2-CdA) increase cytotoxic effect of Ara-C in leukemic blasts inhibit DNA repair mechanisms; therefore its association mitoxantrone (MIT) results a synergistic effect. In the current report, we present final multi-center phase II study evaluating efficacy toxicity CLAG-M salvage regimen poor risk refractory/relapsed patients. Methods:  The induction chemotherapy consisted 2-CdA 5 mg/m2, 2 g/m2, MIT 10 mg/m2, granulocyte-colony stimulating factor. case PR, second was administered. CR received consolidation courses based on high doses or without 2-CdA. Results:  One hundred eighteen patients from 11 centers were registered; 78 resistant 40 relapsed. Sixty-six (58%) achieved after one two CLAG-M, 49 (35%) refractory, 8 (7%) died early. WBC >10 g/L age >34 yr factors associated increased treatment failure. Hematological most prominent this regimen. probability OS at 4 yr 14% (95% CI 4–23%). influenced by age, karyotype both univariate multivariate analyses. DFS 30% for all 66 11–49%). Poor only factor decreased DFS. Conclusions:  We conclude that is well-tolerated highly effective AML.