Efficacy of Venetoclax Plus Cytarabine Versus Idarubicin Plus Cytarabine in Post-Remission Therapy for Elderly Patients with Acute Myeloid Leukemia

The primary objective of the study titled "LAMSA2020" is to evaluate the **efficacy** of Venetoclax combined with Cytarabine compared to Idarubicin combined with Cytarabine as post-remission therapy in elderly patients with **acute myeloid leukemia** (AML) who are in their first remission. This study is clinically relevant as it aims to determine the most effective post-remission treatment regimen for improving outcomes in this patient population, which is particularly vulnerable due to age-related factors and the aggressive nature of AML.

The clinical trial involves **elderly patients** aged 60 years and older diagnosed with **Acute Myeloid Leukemia**. The study population includes both male and female participants, and it does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants. The selection criteria for the trial population, as well as any relevant lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. Key inclusion or exclusion criteria are also not specified by the sponsor.

The clinical trial is a **randomized**, controlled study designed to evaluate the efficacy of Venetoclax combined with Cytarabine versus Idarubicin combined with Cytarabine as post-remission therapy in elderly patients with **Acute Myeloid Leukemia** (AML) in first remission. The trial is conducted in a double-blind manner to ensure unbiased results. The study is categorized as a phase II trial and is expected to span from May 25, 2022, to September 19, 2029, encompassing both recruitment and follow-up periods.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful enrollment, participants will be randomly assigned to one of the treatment arms. Regular follow-up visits will be scheduled to monitor the participants' response to the treatment, assess safety, and collect data on primary and secondary endpoints. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to evaluate the long-term effects of the treatment.

The expected duration of participant involvement in the trial will vary depending on individual response and the overall study timeline. Conditions that may lead to early termination from the study include adverse reactions to the treatment, withdrawal of consent, or any other medical reasons deemed significant by the study investigators. The trial aims to provide valuable insights into the optimal post-remission therapy for elderly patients with AML, contributing to improved treatment strategies in this patient population.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on the administration of other medicinal products or their role in the trial.

Due to the lack of available data, further information on drug administration, dosing schedules, and participant compliance monitoring cannot be described. The trial documentation does not include any additional relevant information regarding the substances involved in the study.

The clinical trial is designed to assess efficacy through a structured evaluation process. As a Phase 4 trial, it will focus on gathering data post-marketing to further evaluate the treatment's effectiveness in a broader patient population. The trial is scheduled to commence recruitment on May 25, 2022, and is estimated to conclude by September 19, 2029. Efficacy assessments will be conducted at predetermined intervals throughout the trial duration, utilizing standardized methods to ensure consistency and reliability of the data collected. The specific parameters or endpoints for evaluating efficacy, such as symptom improvement scores or biomarker levels, are not detailed in the available data. The trial will adhere to rigorous protocols to ensure the accuracy and validity of the efficacy outcomes.