Tokyo, Feb. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060610) titled 'An Interview Study on the Burden and Impact on Daily Life Among Patients with Acute Myeloid Leukemia (AML)' on Feb. 6.

Study Type: Observational

Primary Sponsor: Institute - Fukushima Medical University

Condition: Condition - Acute Myeloid Leukemia Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To investigate the burden experienced by patients with relapsed/refractory acute myeloid leukemia (AML) in their daily lives, and the impact of AML on their daily activities. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Patients with relapsed or refractory AML (including progression from other hematological malignancies such as myelodysplastic syndrome or secondary AML) who are 18 years of age or older at the time of informed consent, and who achieved Complete Remission (CR) or CR with incomplete hematologic recovery (CRi) following pharmacotherapy for the first episode of relapsed/refractory AML. 2) Patients who achieved remission within one year prior to consent following treatment for relapsed or refractory AML. 3) Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 or 1 at the time of consent. 4) Patients capable of participating in a web-based interview of approximately one hour. Key exclusion criteria - 1) Patients who relapsed within one year after achieving CR or CRi following initial standard therapy for AML. 2) Patients who relapsed within one year after undergoing hematopoietic stem cell transplantation (HSCT) as part of initial AML treatment. 3) Patients receiving immunosuppressive therapy following HSCT at the time of consent, those with clinically active graft-versus-host disease (GVHD), or those requiring treatment for GVHD (excluding topical steroid use for skin GVHD). 4) Patients who underwent HSCT after pharmacotherapy for relapsed/refractory AML. 5) Patients with comorbid conditions at the time of consent, including congestive heart failure, uncontrolled infections, human immunodeficiency virus (HIV), active hepatitis B or C, or other active liver diseases. 6) Patients who underwent major surgery or received radiation therapy within 28 days prior to the web interview. 7) Patients with a history of participation in clinical trials targeting relapsed/refractory AML. 8) Patients with a prior diagnosis of dementia. 9) Patients currently undergoing treatment for psychiatric disorders. 10) Patients with active concurrent malignancy (excluding those curatively treated with local therapy). Target Size - 15

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 22 Day Date of IRB - 2025 Year 12 Month 17 Day Anticipated trial start date - 2026 Year 02 Month 10 Day Last follow-up date - 2026 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069327

Disclaimer: Curated by HT Syndication.