455
Participants
Start Date
October 31, 2012
Primary Completion Date
December 31, 2014
Study Completion Date
November 30, 2016
Induction Chemotherapy
"Induction chemotherapy for patients with AML eligible for intensive chemotherapy:~* Cytarabine 200 mg/m2 IV continuous infusion days 1-7~* Daunorubicin 90 mg/m2 intravenous piggyback days 1-3"
Consolidation Chemotherapy
"Consolidation chemotherapy for patients eligible for intensive chemotherapy with low-risk AML or patients with intermediate-/high-risk AML who do not have matched donors:~-Cytarabine 1.5 g/m2 IV in 3 hours days 1, 3 and 5 for 3 cycles"
Autologous Stem Cell Transplantation
"Autologous Stem Cell Transplantation for consolidation of patients eligible for intensive chemotherapy with low-risk AML or patients with intermediate-/high-risk AML who do not have matched donors:~* Busulfan 1 mg/Kg PO q6h or 130 mg/m2 IV once daily days -7 to -4~* Cyclophosphamide 60 mg/Kg IV once daily days -3 and -2"
Allogeneic Stem Cell Transplantation
"Allogeneic Stem Cell Transplantation for consolidation of patients eligible for intensive chemotherapy with intermediate-/high-risk AML~Conditioning regimen:~* Busulfan 1 mg/Kg PO q6h or 130 mg/m2 IV once daily days -7 to -4~* Cyclophosphamide 60 mg/Kg IV once daily days -3 and -2 or Fludarabine 40 mg/m2 IV once daily days -7 to -4"
Low Dose Cytarabine
"Chemotherapy for patients with AML who are not fit for intensive chemotherapy:~* Cytarabine 60 mg/m2 subcutaneous (SQ) bid days 1-5 (until CR or maximum 4 cycles)~* Cytarabine 40 mg/m2 SQ bid days 1-5 (after CR, until a maximum of 3 years of therapy or relapse, whichever comes first)"
Decitabine
"Chemotherapy for patients with AML who are not fit for intensive chemotherapy:~* Decitabine 20 mg/m2 IV once daily days 1-10 (until CR or maximum 4 cycles)~* Decitabine 20 mg/m2 IV once daily days 1-5 (after CR, until a maximum of 3 years of therapy or relapse, whichever comes first)"
Hospital Israelita Albert Einstein, São Paulo
Hospital Israelita Albert Einstein
OTHER