Acute myeloid leukemia
Conditions
Interventions
None listed
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Pathologically or cytogenetically diagnosed acute myeloid leukemia. 2)In the case of acute transformation from MDS or MPN, the time when the patient first fulfills the diagnostic criteria for AML is considered the initial diagnosis, and treatment for MDS or MPN is not included in the history of prior treatment). 3) The patient must be eligible for standard chemotherapy and must be willing to receive treatment. 4) The patient must have reached the age of majority as defined by the Civil Code and must be able to give free and voluntary consent.
Exclusion criteria
Exclusion criteria: 1) Patient is relapsed/refractory or has received prior therapy for AML at the time of enrollment. 2) No indication for or unwillingness to undergo standard chemotherapy 3) Inability to obtain an adequate specimen (bone marrow fluid or peripheral blood) containing myeloblasts 4) The patient has not reached the age of majority or is unable to give free and voluntary consent. 5) Other reasons why the physician in charge considers enrollment in this study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The predictive ability of genomic information at the time of diagnosis for response will be the primary endpoint. To ensure the accuracy of the results, the information obtained from the previous HM-SCREE-Japan studies (HM01 and HM02) will also be integrated into the analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Predictive ability of response as defined in the primary endpoint will be calculated separately for each regimen. 2) Evaluate the turn-around time (TAT) from specimen submission to report return. 3) The rate of concordance between the clinician-determined risk classification and the risk classification based on the ELN2020 classification will be evaluated. 4) Survival and progression-free survival will be evaluated for each risk category. 5) Collect clinical laboratory data (blood samples, bone marrow examination, cytogenetics, etc.) and treatment details (regimen, response determination, etc.) at the time of the screening, and analyze the association between genomic test results and clinical outcomes. 6) Questionnaires will be sent to researchers at each institution to qualitatively or semi-quantitatively evaluate the use of this kit (Amoy Myeloid Panel). | — |
Countries
Japan
Contacts
Public ContactSungGi Chi
National Cancer Center East Department of Hematology
Outcome results
None listed