Refractory/relapsed acute
leukemia has always been a challenging problem for hematologist. Over the past decade emphasis has been made in the development of regimens containing
fludarabine, combined with
cytosine arabinoside for the treatment of refractory/relapsed acute
leukemias. The aim of this study is to evaluate the efficacy and toxicity of the combination of
fludarabine, high dose
cytarabine, and
granulocyte colony stimulating factor in refractory relapsed cases of acute leukaemia, a prospective study is being conducted at the National Center of Hematology and hematology unit/Baghdad teaching hospital from July 2008 to July 2010. Twenty Patients with refractory/relapsed acute
leukemia were treated with
fludarabine 30 mg/m(2) and
cytosine arabinoside (
Ara-C) 2 g/m(2) for 5 days, and
granulocyte colony stimulating factor G-CSF 300 µg/day from day 0 till neutrophil recovery (ANC > 1.0 × 10(9)/L). Response was evaluated by bone marrow examination on day 30 post
chemotherapy. Patients included were refractory
acute lymphoblastic leukemia (ALL) (five patients), relapsed ALL (four patients), refractory
acute myeloid leukemia (AML) (eight patients), relapsed AML (three patients). Complete remission (CR) was achieved in nine (45 %) patients, while three (15 %) patients got partial remission. Three (15 %) patients died because of post
chemotherapy complications and five (25 %) patient failed to achieve remission. Major complications encountered were:
anemia,
fever,
bleeding,
mucositis and
bacterial infections.
FLAG protocol is well tolerated and effective regimen in relapsed/refractory acute
leukemias. The toxicity is acceptable, enabling most patients to receive further treatment, including
transplantation procedures.