Study of Molecular and Genetic Abnormalities in Patients With Myeloid Neoplasms

Patients with Acute Myeloid Leukemia fit for intensive chemotherapy Patients will receive Induction Chemotherapy, and CR will be evaluated after 28 days.

Patients who achieve CR post-induction chemotherapy will receive post-remission therapy according to risk:

• Low risk patients: Consolidation chemotherapy or Autologous stem cell transplantation
• Intermediate and high-risk patients: Allogeneic stem cell transplantation Patients who do not achieve CR may receive one second induction cycle, and if CR is achieved may proceed to post-remission therapy as per above. Patients who do not achieve CR after two cycles of induction will be deemed refractory and removed from the study.

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

• Ara-C
• Antraciclina
• 7+3
• Daunorubicina
• 3+7

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

• Ara-C
• Citarabina

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

• ASCT
• ABMT
• Autologous Bone Marrow 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

• AlloSCT
• Trapianto Allogenico Di Midollo Osseo

Patients with acute myeloid leukemia not fit for intensive chemotherapy Patients will receive induction chemotherapy with either low dose cytarabine or decitabine. Assignment to each drug will depend on drug availability and physician discretion. No randomization will be done between the drugs.

Cycles will be repeated every 28 days. Patients who achieve CR will continue to post-consolidation therapy with either cytarabine or decitabine, based on the induction therapy received. Patients will receive a maximum of 4 cycles until achieving CR, if no response is seen after 4 cycles patients will be deemed refractory.

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)

• Low dose ara-C
• LDAC

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)

• Dacogeno
• DAC
• 2-aza-5´-deoxycytidine

Patients with Chronic Myeloid Disorders:

• Myeloproliferative Neoplasms
• Myelodysplastic Syndromes
• Myeloproliferative/Myelodysplastic Neoplasms