Table 4a.
Response criteria in ALL
|
Complete Remission (CR): A CR requires that all of the following be recorded concurrently: • < 5% marrow leukemia blast cells (M1). • No circulating blasts. • Absolute neutrophil count (neutrophils and bands) ≥ 1.0 × 109/L. • Platelet count ≥ 100 × 109/L. • Adequate bone marrow cellularity with trilineage hematopoiesis. • Absence of extramedullary manifestations of disease (e.g., CNS1). • No evidence of recurrence of ALL for at least 4 weeks. |
| *Morphologic CR with incomplete blood count recovery (CRi): Above CR criteria without specified blood counts. |
| Cytogenetic CR (CRc): In addition to above CR criteria, reversion to normal karyotype for those with previously detected cytogenetic abnormality. |
| Molecular CR (CRm): In addition to above CRc criteria, normalization of previously detected molecular cytogenetic abnormality. |
|
*Partial Response (PR): Requires that all of the following be recorded concurrently: • Decrease in the percentage of marrow blasts, absolute peripheral blast count, and extramedullary disease by at least 50%. • ≤ 25% marrow leukemia blast cells. • Absolute neutrophil count (neutrophils and bands) ≥ 1.0 × 109/L. • Platelet count ≥ 100 × 109/L. |
|
*Stable Disease (SD) • Criteria not met for CR, PR, or progression. |
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Progressive Disease • An increase of at least 25% in the absolute number of circulating or bone marrow leukemic blasts or extramedullary disease burden; or • Development of new extramedullary disease. |
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Relapsed Disease • The reappearance of leukemia blast cells in the blood or the bone marrow (≥ 25%) or in any other extramedullary site after a CR with confirmation of lymphoid blasts by morphology and flow cytometry, PCR for antigen receptor loci or fusion genes, or cytogenetics/FISH; or • Increase to > 25% blasts in the marrow after a PR. • Importantly, isolated extramedullary relapses (e.g., CNS) are considered relapse from a diagnostic standpoint, although these are commonly approached differently in terms of therapy. |
*
Additional definitions sometimes employed in the context of clinical trial