Tokyo, Aug. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058338) titled 'Genomic screening study in patients with newly-diagnosed untreated acute myeloid leukemia' on Aug. 1.

Study Type: Observational

Primary Sponsor: Institute - National Cancer Center

Condition: Condition - Acute myeloid leukemia Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - To identify patients with high-risk AML according to new criteria defined by genetic mutations and to determine the response factors (including genetic information) to standard chemotherapy, including Vyxeos(R), for these patients. In addition, we will verify whether the Amoy DX(R) Myeloid Blood Cancer Panel is of sufficient quality for clinical use in terms of time and accuracy of the test. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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. Key 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. Target Size - 150

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 05 Month 07 Day Anticipated trial start date - 2025 Year 08 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066692

Disclaimer: Curated by HT Syndication.