Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
, 5 (3), 982-986

Clinical Study of Mito-FLAG Regimen in Treatment of Relapsed Acute Myeloid Leukemia


Clinical Study of Mito-FLAG Regimen in Treatment of Relapsed Acute Myeloid Leukemia

Sheng Luo et al. Exp Ther Med.


Patients with relapsed acute myeloid leukemia (AML) have unfavorable prognosis and require innovative therapeutic approaches. In this study we used fludarabine combined with a middle dose of cytosine arabinoside (Ara-C), mitoxantrone and granulocyte-colony stimulating factor (G-CSF) as a salvage therapy for patients with relapsed AML in China. Forty-five patients with relapsed AML were treated with the Mito-FLAG regimen consisting of mitoxantrone (7 mg/m(2), day 1, 3 and 5), fludarabine (30 mg/m(2), days 1-5), Ara-C (1 g/m(2), over 3 h every 12 h, days 1-5) and G-CSF [5 μg/kg/day subcutaneously from day 0 until the white blood count (WBC) was >20×10(9)/l]. Patients with a partial response (PR) received another course of the same regimen. Patients with a suitable donor and aged <50 years received allogeneic stem cell transplantation (allo-SCT). Twenty-three patients (51%) and 3 patients (7%) achieved complete remission (CR) and PR, respectively, following one or two courses of Mito-FLAG, and the overall response (OR) rate was 58%. Nine patients (20%) received allo-SCT and 4 patients (9%) succumbed early. Hematological toxicity and infections were the most prominent toxicities of this regimen. Other toxicities included nausea, vomiting, bleeding, hyperbilirubinemia, renal toxicity and arrhythmia. The probability of overall survival (OS) at 4 years was 19% (95% CI, 11-26%) and the probability of 4-year disease-free survival (DFS) was 29% for all 23 patients in CR (95% CI, 18-41%). Our data suggest that Mito-FLAG is a highly effective and well-tolerated salvage regimen for relapsed AML.

Keywords: Mito-FLAG; fludarabine; relapsed acute myeloid leukemia; salvage chemotherapy.


Figure 1.
Figure 1.
Kaplan-Meier curve for OS in relapsed AML patients treated with Mito-FLAG. OS, overall survival; AML, acute myeloid leukemia.
Figure 2.
Figure 2.
Kaplan-Meier curve for DFS in relapsed AML patients achieving CR. DFS, disease-free survival; AML, acute myeloid leukemia; CR, complete remission.
Figure 3.
Figure 3.
Kaplan-Meier curve for OS in relapsed AML patients undergoing allo-SCT. OS, overall survival; AML, acute myeloid leukemia; allo-SCT, allogeneic stem cell transplantation.

Similar articles

See all similar articles

Cited by 5 articles


    1. Löwenberg B, Downing JR, Burnett A. Acute myeloid leukemia. N Engl J Med. 1999;341:1051–1062. - PubMed
    1. Estey E, Döhner H. Acute myeloid leukaemia. Lancet. 2006;368:1894–1907. - PubMed
    1. Roboz GJ. Novel approaches to the treatment of acute myeloid leukemia. Hematology Am Soc Hematol Educ Program. 2011;2011:43–50. - PubMed
    1. Gandhi V, Estey E, Keating MJ, Plunkett W. Biochemical modulation of arabinosylcytosine for therapy of leukemias. Leuk Lymphoma. 1993;10:109–114. - PubMed
    1. Lee SR, Yang DH, Ahn JS, Kim YK, Lee JJ, Choi YJ, Shin HJ, Chung JS, Cho YY, Chae YS, Kim JG, Sohn SK, Kim HJ. The clinical outcome of FLAG chemotherapy without idarubicin in patients with relapsed or refractory acute myeloid leukemia. J Korean Med Sci. 2009;24:498–503. - PMC - PubMed