Efficacy and Toxicity of Increasing Doses of Idarubicin, Cytarabine and G-CSF in Acute Myeloid Leukemia
Di Novo Acute Myeloid Leukemia
About this trial
This is an interventional treatment trial for Di Novo Acute Myeloid Leukemia focused on measuring acute, myeloid, leukemia, CETLAM, Idarubicin
Eligibility Criteria
Inclusion Criteria:
Informed consent signature Patients with newly diagnosed AML, classified according to WHO criteria. Age more than or equal to 18 and less than or equal to 70 years.
Exclusion Criteria:
Patients previously treated with chemotherapy for their AML other than hydroxyurea.
Acute promyelocytic leukemia with t (15; 17). Blast crisis of chronic myeloid leukemia. Leukemias that appear after other myeloproliferative neoplasms. Leukemias ensuing myelodysplastic syndromes after more than 6 months. Presence of other malignancies in activity. AML secondary to chemo-radiotherapy treatment for other malignancies. Abnormal renal and hepatic function, with creatinine value and / or bilirubin 2 times the normal limit value, except where the alterations are attributable to leukemia.
Patients with markedly reduced ejection fraction (less than 45%), symptomatic heart failure, or both of the normal value of the center.
Patients with serious concomitant psychiatric or neurological disease. HIV-positive. Pregnancy or breastfeeding
Sites / Locations
- Hospital Universitari Germans Trias I Pujol de Badalona
- Hospital de La Santa Creu I Sant Pau
- Hospitals Vall D'Hebron
- Hospital Clinic I Provincial de Barcelona
- Hospital Clínico Universitario de Valencia
Arms of the Study
Arm 1
Experimental
Idarubicin
Cohort 1: Idarubicin 14 mg/m2 (day 1-3), Cytarabine 200 mg/m2 (Days 1-7), G-CSF 150 mcg/m2/day Cohort 2: Idarubicin 16 mg/m2 (day 1-3), Cytarabine 200 mg/m2 (Days 1-7), G-CSF 150 mcg/m2/day Cohort 3: Idarubicin 18 mg/m2 (day 1-3), Cytarabine 200 mg/m2 (Days 1-7), G-CSF 150 mcg/m2/day