Evaluation of PXS-5505 Combined with 5-Azacitidine in Patients with Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia

The primary objective of the AZALOX Study is to evaluate the **safety** and **efficacy** of the investigational drug PXS-5505 in combination with 5-Azacitidine in patients diagnosed with **Myelodysplastic Neoplasms (MDS)** and **Chronic Myelomonocytic Leukemia (CMML)**. This study aims to determine the potential therapeutic benefits and safety profile of this combination treatment, which is clinically relevant for improving patient outcomes in these hematological disorders. No secondary objectives are provided in the available data.

The clinical trial involves participants diagnosed with **Myelodysplastic Neoplasms (MDS)** and **Chronic Myelomonocytic Leukemia (CMML)**. The study population includes both male and female subjects, with an age range encompassing adults and older adults. The trial population selection criteria include individuals from a vulnerable population, although specific details regarding the total number of participants have not been provided by the sponsor. Participants' general health status, lifestyle considerations such as diet, physical activity, and habits, as well as key inclusion or exclusion criteria, are not detailed in the available data.

The clinical trial is designed to evaluate the safety and efficacy of PXS-5505 in combination with 5-Azacitidine for patients diagnosed with **Myelodysplastic Neoplasms (MDS)** and **Chronic Myelomonocytic Leukemia (CMML)**. The study is structured as a randomized, double-blind, controlled trial, ensuring that neither the participants nor the researchers know who is receiving the treatment or placebo, thus minimizing bias. The trial is set to commence recruitment on May 1, 2025, and is expected to conclude by June 30, 2028, providing a comprehensive evaluation period.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria are assessed. This is followed by regular follow-up visits to monitor the participants' health and response to the treatment. The sequence of these visits is crucial for collecting consistent data and ensuring participant safety. The end-of-study visit marks the final assessment, where the overall health and outcomes of the participants are evaluated.

The expected length of participant involvement in the trial is approximately three years, aligning with the overall trial duration. However, certain conditions may lead to early termination from the study, such as adverse reactions to the treatment, withdrawal of consent, or non-compliance with the study protocol. These measures are in place to protect the participants' well-being and maintain the integrity of the trial data.

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 additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of this data limits the ability to describe the treatment protocols accurately.

The clinical trial will assess efficacy through a structured evaluation process. The trial is scheduled to commence recruitment on May 1, 2025, with an estimated completion date of June 30, 2028. The trial is categorized under phase 8, indicating an advanced stage of clinical research. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, the trial will likely employ standard methodologies for measuring and analyzing efficacy outcomes. These may include validated scales, laboratory tests, or patient-reported outcomes, assessed at predetermined timepoints throughout the trial duration. The absence of explicit endpoints suggests that the trial may focus on comprehensive data collection to evaluate the therapeutic impact of the intervention under investigation. The trial's design will adhere to rigorous scientific standards to ensure the reliability and validity of the efficacy assessments.