Patient has acute promyelocytic leukemia (APML)
Patients with Down syndrome, acute promyelocytic leukemia, juvenile myelomonocytic leukemia, or bone marrow failure syndromes are not eligible
Newly diagnosed with acute myelogenous leukemia (except acute promyelocytic leukemia) and has failed one or two prior standard induction attempts. Failure is defined as:
Acute promyelocytic leukemia
Diagnosis of acute promyelocytic leukemia (M3 classification)
Subject has acute promyelocytic leukemia
Participant has acute promyelocytic leukemia
Subjects diagnosed with Acute Promyelocytic Leukemia.
Acute Promyelocytic Leukemia
Patients with a diagnosis of acute promyelocytic leukemia
Acute promyelocytic leukemia with PML-RARA or t(15;17)
Acute promyelocytic leukemia
Patients with acute promyelocytic leukemia
Patients who have received any therapy other than hydroxyurea or ATRA with the purpose of treating their AML or patients with acute promyelocytic leukemia are not eligible
Acute promyelocytic leukemia
Diagnosis of acute promyelocytic leukemia
Has a diagnosis of acute promyelocytic leukemia.
Subjects with acute promyelocytic leukemia (M3)
AML is of the sub-type of acute promyelocytic leukemia
Has acute promyelocytic leukemia (AML subtype M3)
Acute promyelocytic leukemia
Acute promyelocytic leukemia
Acute promyelocytic leukemia
Subject has a diagnosis of acute promyelocytic leukemia
Acute Promyelocytic Leukemia
Patients with acute promyelocytic leukemia
Acute promyelocytic leukemia (FAB M3)
Acute Promyelocytic Leukemia (AML subtype M3).
Subject has acute promyelocytic leukemia.
Unequivocal diagnosis of AML based on the WHO classification, excluding acute promyelocytic leukemia
Acute promyelocytic leukemia (FAB M3 classification)
Acute promyelocytic leukemia
Acute Promyelocytic Leukemia
Diagnosis of acute promyelocytic leukemia
Patients with acute promyelocytic leukemia are excluded
Acute promyelocytic leukemia with t(15;17)(q22;q12) and/or PML-RARA molecular rearrangement
Dose Escalation: Acute Promyelocytic Leukemia
Have acute promyelocytic leukemia and the associated cytogenic translocation t:(15/17)
Diagnosis of AML-M3 (or acute promyelocytic leukemia)
Acute promyelocytic leukemia (AML with t[15;17][q22;q11] and variants)
Diagnosis of acute promyelocytic leukemia
Acute promyelocytic leukemia [t(15;17)]
Patients with acute promyelocytic leukemia
Diagnosis of AML-M3 (or acute promyelocytic leukemia)
Acute promyelocytic leukemia [t(15;17)] or favorable cytogenetics, including t(8;21) or inv16 if known at the time of randomization.
The patient must not have acute promyelocytic leukemia or t(15;17) observed by FISH
Acute promyelocytic leukemia
Subjects with a diagnosis of Acute Promyelocytic Leukemia
Promyelocytic leukemia
Patients with a diagnosis of acute promyelocytic leukemia (according to WHO classification 2008)
Subjects with the diagnosis of acute promyelocytic leukemia (t[15;17])
All subtypes of Acute Myeloid leukemia (except for acute promyelocytic leukemia)
Diagnosis of acute promyelocytic leukemia
Patients with acute promyelocytic leukemia according to WHO definition.
Acute promyelocytic leukemia or AML with a t(15;17) (q22;q12) cytogenetic abnormality or Bcr/Abl positive leukemia
Acute promyelocytic leukemia
Acute promyelocytic leukemia with t(15;17), or its molecular equivalent (PML-RARalpha)
Newly Diagnosed De novo AML according to WHO criteria except for Acute Promyelocytic Leukemia or patients with known favorable cytogenetics (see exclusion)
Newly diagnosed patients with Acute promyelocytic leukemia [t(15;17)] or favorable cytogenetics, including t(8;21) or inv16
A diagnosis of acute promyelocytic (M3) or acute megakaryocytic leukaemia (M7).
Acute promyelocytic leukemia.
Documented/confirmed acute myelogenous leukemia (AML), except for acute promyelocytic leukemia
Diagnosis of acute promyelocytic leukemia
The patient has acute promyelocytic leukemia with t(15;17) (q22;q12), (PML/RAR?) or variants.
Diagnosis of acute promyelocytic leukemia
The patient has acute promyelocytic leukemia with t(15;17)(q22;q12), (PML/RAR?) or variants.
Newly Diagnosed De novo AML according to WHO criteria except for Acute Promyelocytic Leukemia or patients with known favorable cytogenetics
Newly diagnosed patients with Acute promyelocytic leukemia [t(15;17)] or favorable cytogenetics, including t(8;21) or inv16
A diagnosis of acute promyelocytic leukemia (APML)
Acute promyelocytic leukemia
Patients with acute promyelocytic leukemia
Patients with acute promyelocytic leukemia
Acute promyelocytic leukemia
Patients with a diagnosis of acute promyelocytic leukemia
AML subtype M3 (promyelocytic leukemia)
Patients must have a documented Unequivocal diagnosis of AML according to WHO 2008 classification (>20% blasts in the bone marrow), excluding M3 (acute promyelocytic leukemia).
Acute promyelocytic leukemia.
Diagnosis of acute promyelocytic leukemia
Acute promyelocytic leukemia (M3 classification).
Acute promyelocytic leukemia
Primary or secondary AML (including erythroleukemia and eosinophilic leukemia, but excluding acute promyelocytic leukemia)
Diagnosis of promyelocytic leukemia