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| # | Blank 1 | Frequency | Blank 2 | Frequency | |
|---|---|---|---|---|---|
| 1 | 1 | imatinib or dasatinib respectivelyradiotherapy n with a wide field of radiation within 4 weeks or radiotherapy with a limited field of n radiation for palliation within 1 week of the first dose of study treatment . n n cns irradiation for meningeal leukemia except | 1 | they have < 5 marrow blasts at time of transplant | 2 |
| 2 | 2 | chronic myeloid leukemia cml patients in chronic phase 1 cp1 must have failed or be intolerant of tyrosine kinase inhibitors tkis patients beyond cp1 will be accepted | 1 | recent chemotherapy has not resmcLted in mrd negative status | 2 |
| 3 | 3 | chronic myeloid leukemia cml patients in cp1 must have failed or be intolerant of tyrosine kinase inhibitors tkis patients beyond cp1 will be accepted | 1 | radiotherapy occurred > = 3 months n previously . at least four weeks must have elapsed since prophylactic cns irradiation n given as part of a front line therapy regimen for all n n major surgery within 2 weeks before the first dose of study treatment n n other protocol defined inclusion / exclusion criteria may apply | 1 |
| 4 | 4 | mrd positive leukemia aml all or accelerated / blast phase chronic myeloid leukemia cml selected patients in morphologic cr but with positive immunophenotypic flow cytometry or molecmcLar evidence of mrd may be eligible | 1 | they are in complete cytogenetic response ccyr | 1 |
| 5 | 5 | cml cp patients are excluded | 1 | they are in major hematologic response mahr . | 1 |
| 6 | 6 | patients with cml ap cml bp or ph all are excluded | 1 | they are beyond chronic phase cp 1 and if they have received previous myelosuppressive chemotherapy or hct and have < 5 marrow blasts at time of transplant | 1 |
| 7 | 7 | chronic myeloid leukemia cml accepted | 1 | this dose is also acceptable for chronic phase patients the phase ii will be conducted in two treatment arms as follows treatment arm a advanced phase disease and treatment arm b therapy for chronic phase cp cml refractory / resistant / suboptimally responding to at least two prior tyrosine kinase inhibitors tkis cml ap is defined by the presence of one of the following a . 15 29 blasts in peripheral blood pb or bone marrow bm b . > = 20 basophils in pb or bm c . > = 30 blasts plus promyelocytes with blasts < 30 in pb or bm d . < 100 000 / mcL Platelets unrelated to therapy | 1 |
| 8 | 8 | a cohort of 6 patients with cml chronic phase who have failed prior therapy with at least two tyrosine kinase inhibitor will be treated at the mtd to determine | 1 | only present at the time of diagnosis and not associated with other features of accelerated phase cml bp is defined by the presence of > = 30 blasts in the bone marrow and / or peripheral blood or the presence of extramedmcLlary disease with myeloid or lymphoid blast morphology philadelphia chromosome acute leukemias are eligible and defined by > = 20 blasts in the peripheral blood or bone marrow at the time of diagnosis | 1 |
| 9 | 9 | or clonal cytogenetics evolution i . e . the presence of cytogenetic abnormalities other than the philadelphia chromosome except | 1 | they have shown intolerance to tyrosine kinase inhibitors or are beyond first chronic phase cp1 and if they have received previous myelosuppressive chemotherapy or hct and have < 5 marrow blasts at time of transplant | 1 |
| 10 | 10 | chronic myeloid leukemia cml patients will be accepted | 1 | required from the perspective of tolerance for bcr abl positive cml in documented chronic phase at the time of diagnosis | 1 |
| 11 | 11 | minimum of 2 calendar years of nilotinib treatment with at least the last 12 months of nilotinib treatment prior to pre screening at approved total dialy dose of 600 mg bid or at a reduced dose of 400 mg qd | 1 | clinically indicated to control disease . in such cases | 1 |
| 12 | 12 | in patients with rapidly proliferating disease hydroxyurea may be administered before study entry | 1 | their disease has failed to respond and / or they are intolerant to the available tyrosine kinase inhibitors tkis | 1 |
| 13 | 13 | patients with chronic myelogenous leukemia cml in myeloid blast crisis are eligible | 1 | cytogenetics are normal and there is polymerase chain reaction pcr evidence of a bcr / abl fusion patients will be eligible if they have evidence of a quantitative increase in cml measured either by quantitative pcr or by fluorescent in situ hybridization fish r n for chronic phase cml patients only r n must have failed no response in 3 months or incomplete response at 6 months or refused treatment with a tyrosine kinase inhibitor tki r n must have failed defined as incomplete response or relapse or refused donor lymphocyte infusion dli | 1 |
| 14 | 14 | mrd positive leukemia aml all or accelerated / blast phase chronic myelogenous leukemia cml selected patients in morphologic cr but with positive immunophenotypic flow cytometry or molecmcLar evidence of mrd may be eligible | 1 | available | 1 |
| 15 | 15 | relapse will be defined as any cytogenetic evidence of a philadelphia chromosome or persistence of breakpoint cluster region bcr / c abl oncogene 1 non receptor tyrosine kinase abl rearrangements by molecmcLar testing on at least two measurements over a 6 month interval | 1 | NA | |
| 16 | 16 | 1 | NA |