Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p187
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 187/381)
Character Range: 12757324–12763145

greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or
                                                                                                                                                                    (5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); OR
                                                                                                                                                                    (v) Disease progression (defined as a greater than or equal to.
                                                                                                                                                                    - failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or dasatinib for patients initially treated in chronic phase; or
                                                                                                                                                                    - failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or dasatinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or
                                                                                                                                                                    - failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or dasatinib; OR
                                                                                                                                                                    (ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or dasatinib therapy; OR
                                                                                                                                                                    (iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or dasatinib therapy; OR
                                                                                                                                                                    (iv) Development of accelerated phase in a patient previously prescribed imatinib or dasatinib for the chronic phase of chronic myeloid leukaemia.
                                                                                                                                                                    (1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or
                                                                                                                                                                    (2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or
                                                                                                                                                                    (3) Peripheral basophils greater than or equal to 20%; or
                                                                                                                                                                    (4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or
                                                                                                                                                                    (5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); OR
                                                                                                                                                                    (v) Disease progression (defined as a greater than or equal to.
                                                                                                                                                                    Accelerated phase is defined by the presence of 1 or more of the following
                                                                                                                                                                    (1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or
                                                                                                                                                                    (2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or
                                                                                                                                                                    (3) Peripheral basophils greater than or equal to 20%; or
                                                                                                                                                                    (4) Progressive splenomegaly to a size greater than or