Clinical Trial: Study on the inter-individual variability of venetoclax blood concentrations and its association with efficacy and safety (Japan)

Tokyo, Jan. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060501) titled 'Study on the inter-individual variability of venetoclax blood concentrations and its association with efficacy and safety' on Jan. 28.

Study Type: Observational

Primary Sponsor: Institute - Kyoto University

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

Objective: Narrative objectives1 - The primary objective of this study is to identify factors contributing to the inter-individual variability of venetoclax trough levels in patients with acute myeloid leukemia (AML). Specifically, we aim to analyze the impact of concomitant medications (such as CYP3A-inhibiting antifungal agents), hepatic and renal function, and patient-specific background factors on venetoclax exposure. The study evaluates the association between trough levels and hematologic toxicities (safety) as well as treatment response rates (efficacy). Through these analyses, we aim to establish evidence-based indices for personalized dosing to optimize efficacy while minimizing the risk of adverse events in actual clinical practice. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients who are receiving or have received venetoclax. Patients diagnosed with acute myeloid leukemia. Patients aged 18 years or older at the time of enrollment. Patients who have received a sufficient explanation regarding the study and provided written informed consent from themselves or their legal representative. Key exclusion criteria - Patients with poor medication adherence Patients receiving venetoclax monotherapy or combination therapy with agents other than azacitidine Patients whose venetoclax dose was not adjusted appropriately according to concomitant medications, such as CYP3A inhibitors. Target Size - 100

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2021 Year 05 Month 17 Day Date of IRB - 2021 Year 05 Month 17 Day Anticipated trial start date - 2021 Year 05 Month 17 Day Last follow-up date - 2025 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069216

Disclaimer: Curated by HT Syndication.