| Complete remission (CR)* |
Bone marrow blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count > 1.0 × 109/l; platelet count > 100 × 109/l; independence of red cell transfusions |
| CR with incomplete recovery (CRi) |
All CR criteria except for residual neutropenia (< 1.0 × 109/l) or thrombocytopenia (< 100 × 109/l) |
| Morphological leukaemia-free state |
Bone marrow blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; no haematological recovery required |
| Partial remission (PR) |
Relevant in the setting of Phase 1 and 2 clinical trials only; all haematological criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50% |
| Cytogenetic CR (CRc) |
Reversion to a normal karyotype at the time of morphological CR (or CRi) in cases with an abnormal karyotype at the time of diagnosis; based on the evaluation of 20 metaphase cells from bone marrow |
| Resistant disease (RD) |
Failure to achieve CR or CRi (general practice; Phase 2/3 trials), or failure to achieve CR, CRi, or PR (Phase 1 trials); only includes patients surviving ≥ 7 days following completion of initial treatment, with evidence of persistent leukaemia by blood and/or bone marrow examination |
| Death in aplasia |
Death occurring ≥ 7 days following completion of initial treatment while cytopenic; with an aplastic or hypoplastic bone marrow obtained within 7 days of death, without evidence of persistent leukaemia |
| Death from indeterminate cause |
Death occurring before completion of therapy, or < 7 days following its completion; or deaths occurring ≥ 7 days following completion of initial therapy with no blasts in the blood, but no bone marrow examination available |
| Relapse |
Bone marrow blasts ≥ 5%; or reappearance of blasts in the blood; or development of extramedullary disease |
