Criteria

MD Anderson Cancer Center criteria[2][26]

Subsequent to the introduction of tyrosine kinase inhibitor (TKI) therapy, many clinical trials employ MD Anderson Cancer Center (MDACC) criteria for advanced phase CML.[2]

MDACC criteria and International Bone Marrow Transplant Registry criteria are favoured in clinical practice.

One or more of the following:

  • Blasts ≥30% blasts in the blood, bone marrow, or both

  • Extramedullary blasts (apart from the spleen).

International Bone Marrow Transplant Registry criteria[2][26]

One or more of the following:

  • Blasts ≥30% blasts in the blood, bone marrow, or both

  • Extramedullary blasts (apart from the spleen).

World Health Organization (WHO) criteria​​​[1]

  • ≥20% myeloid blasts in the blood or bone marrow, or

  • The presence of an extramedullary proliferation of blasts, or

  • The presence of increased lymphoblasts in peripheral blood or bone marrow.[Figure caption and citation for the preceding image starts]: Arrow: chronic myeloid leukaemia blast cells with neutrophils in various stages of maturationDr Bruce Villas, Department of Pathology, University of Florida College of Medicine, Jacksonville, FL; used with permission [Citation ends].com.bmj.content.model.Caption@4ece960e

International consensus classification of myeloid neoplasms and acute leukaemias[27]

  • ≥20% bone marrow or peripheral blood blasts

  • Extramedullary blast proliferation.

Presence of morphologically apparent lymphoblasts (>5%) warrants consideration of lymphoblastic crisis (and immunophenotypic analysis to confirm lymphoid lineage).

European LeukemiaNet criteria[28]

One or more of the following:

  • Blasts in blood or marrow ≥30%

  • Extramedullary blast proliferation (apart from spleen).

Therapeutic response criteria for CML[2]

Complete haematological response:

  • Complete normalisation of peripheral counts and differential (white blood cell count <10 × 10⁹/L [<10,000/microlitre]; platelet count <450 × 10⁹/L [<450,000/microlitre])

  • No signs and symptoms of CML, including palpable splenomegaly

  • No immature myeloid cells (myelocytes, promyelocytes, or blasts) in peripheral blood.

Partial haematological response:

  • Persistence of few immature myeloid cells, or

  • Persistence of splenomegaly but >50% improvement from baseline, or

  • Mild thrombocytosis.

Cytogenetic response is based on the percentage of Philadelphia-positive metaphases:

  • Complete: 0%

  • Partial: 1% to 35%

  • Major: includes complete and partial responses (i.e., ≤35%)

  • Minor: 36% to 65%

  • Minimal: 66% to 95%

  • None: >95%.

Molecular response (MR):

  • Early: BCR::ABL1 (International Scale [IS]) ≤10% at 3 and 6 months

  • Major: BCR::ABL1 (IS) ≤0.1% (or ≥3-log reduction in BCR::ABL1 mRNA from the standardised baseline, if quantitative polymerase chain reaction is not available)

  • Deep: defined as MR4.0: BCR::ABL1 (IS) ≤0.01%; or MR4.5: BCR::ABL1 (IS) ≤0.0032%.

Relapse:

  • Any sign of loss of haematological response

  • Any loss of sign of loss of complete cytogenetic response or its molecular response correlate defined as an increase in BCR::ABL1 transcript to >1%

  • 1-log increase in BCR::ABL1 transcript levels with loss of major molecular response.

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