A perspective multi-centre random open parallel case-controlled trial of treatment of relapsed and refractory acute myeloid leukemia with Fludarabine, Cytarabine with or without G-CSF

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2008
INTERVENTION: Fludarabine+Cytarabine+G‐CSF(FLAG):Fludarabine 30mg/m^2/d d1‐5; Cytarabine 1.5g/m^2/d;Fludarabine+Cytarabine (FA):Fludarabine 30mg/m^2/d d1‐5; Cytarabine 1.5g/m^2/d; CONDITION: Acute Myeloid Leukemia PRIMARY OUTCOME: Complete remission rate;Partial remission rate;Security Assessment; SECONDARY OUTCOME: median duration of complete remission; INCLUSION CRITERIA: The diagnosis is consistant with the FAB criteria for acute myeloid leukemia (not acute promyelocytic leukemia). The criteria for relapsed and refractory leukemia is referred to The 6th National Leukemia Conference (1991). Refractory leukemia is defined as 1. The newly diagnosed patient did not achieve complete remission after two cycles of standard regimen (HA and DA) ; 2. After complete remission, the first relapse occurred within 6 months during consolidation; or relapse after 6 month, but refractory to standard therpy; 3. multiple replased patients.
Epistemonikos ID: 2b0c029b00d0c31b893868cd0bdaef0bdc91e8e8
First added on: Aug 21, 2024