Version May 2024
| Category | Definition | Comment |
| Response | ||
| CR without minimal residual disease (CRMRD–) | If studied pretreatment, CR with negativity for a genetic marker by RT–qPCR, or CR with negativity by MFC | Sensitivities vary by marker tested, and by method used; therefore, test used and sensitivity of the assay should be reported; analyses should be done in experienced laboratories (centralized diagnostics) |
| Complete remission (CR) | Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC ≥1.0 × 109/L (1000/microL); platelet count ≥100 × 109/L (100,000/microL) | MRD+ or unknown |
| CR with incomplete hematologic recovery (CRi) | All CR criteria except for residual neutropenia (<1.0 × 109/L [1000/microL]) or thrombocytopenia (<100 × 109/L [100,000/microL]) | |
| Morphologic leukemia-free state (MLFS) | Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required | Marrow should not merely be "aplastic"; at least 200 cells should be enumerated or cellularity should be at least 10% |
| Partial remission (PR) | All hematologic 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% | Especially important in the context of phase 1/2 clinical trials |
| Treatment failure | ||
| Primary refractory disease | No CR or CRi after 2 courses of intensive induction treatment; excluding patients with death in aplasia or death due to indeterminate cause | Regimens containing higher doses of cytarabine are generally considered as the best option for patients not responding to a first cycle of 7+3; the likelihood of responding to such regimens is lower after failure of a first |
| Death in aplasia | Deaths 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 leukemia | |
| Death from indeterminate cause | Deaths 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 | |
| Response criteria for clinical trials only | ||
| Stable disease | Absence of CRMRD–, CR, CRi, PR, MLFS; and criteria for PD not met | Period of stable disease should last at least 3 months |
| Progressive disease (PD)*¶ | Evidence for an increase in bone marrow blast percentage and/or increase of absolute blast counts in the blood:
| Category mainly applies for older patient given low-intensity or single-agent "targeted therapies" in clinical trials In general, at least 2 cycles of a novel agent should be administered Some protocols may require blast increase in 2 consecutive marrow assessments at least 4 weeks apart; the date of progression should then be defined as of the first observation date Some protocols may allow transient addition of hydroxyurea to lower blast counts "Progressive disease" is usually accompanied by a decline in ANC and platelets and increased transfusion requirement and decline in performance status or increase in symptoms |
| Relapse | ||
| Hematologic relapse (after CRMRD–, CR, CRi) | Bone marrow blasts ≥5%; or reappearance of blasts in the blood; or development of extramedullary disease | |
| Molecular relapse (after CRMRD–) | If studied pretreatment, reoccurrence of MRD as assessed by RT–qPCR or by MFC | Test applied, sensitivity of the assay, and cutoff values used must be reported; analyses should be done in experienced laboratories (centralized diagnostics) |
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