Phase I/II Evaluation of 177Lu-PentixaTher Radioligand Therapy in Relapsed/Refractory CXCR4-Positive Acute Leukemia

The primary objective of this Phase I/II study is to evaluate the efficacy and safety of **radioligand therapy (RLT)** using **177Lu-PentixaTher** in patients with relapsed or refractory **CXCR4+ acute leukemia**. This investigation is clinically relevant as it aims to address the therapeutic challenges associated with treatment-resistant forms of acute leukemia, potentially offering a novel therapeutic option for patients who have limited treatment alternatives.

The clinical trial focuses on **Acute Leukemia** and includes both male and female participants. The study population comprises individuals from two age categories, specifically adults and adolescents. The trial involves a vulnerable population, indicating that special considerations are in place to ensure the safety and ethical treatment of participants. The sponsor has not provided information regarding the total number of participants. The selection process for the trial population and any lifestyle considerations such as diet, physical activity, or habits have not been disclosed. Key inclusion or exclusion criteria have not been specified by the sponsor.

The clinical trial is designed to evaluate the efficacy and safety of **radioligand therapy** using 177Lu-PentixaTher in patients with relapsed or refractory **acute leukemia** expressing CXCR4. This study is structured as a Phase I/II trial, incorporating a randomized, double-blind, and controlled design to ensure robust and unbiased results. The trial is expected to commence recruitment on February 15, 2024, and is projected to conclude by February 15, 2027, encompassing a total duration of approximately three years.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, to assess eligibility based on predefined criteria. Following successful enrollment, participants will attend regular follow-up visits to monitor treatment response and any adverse events. These visits are crucial for collecting data on the primary and secondary endpoints of the study. The end-of-study visit will mark the completion of the participant's involvement, during which final assessments will be conducted to evaluate the overall outcomes of the therapy.

The expected length of participant involvement will vary depending on individual response to treatment and the specific phase of the trial they are enrolled in. Conditions that may lead to early termination from the study include significant adverse reactions, withdrawal of consent, or any other medical reasons deemed necessary by the investigator. The trial's methodology and design are meticulously crafted to ensure the collection of high-quality data, contributing to the understanding of the therapeutic potential of 177Lu-PentixaTher in treating acute leukemia.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the **experimental medication**, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the lack of specific information, additional relevant details about drug administration, dosing schedules, and participant compliance monitoring are also not included. The absence of data on the **experimental medication** and non-experimental treatments limits the ability to provide a comprehensive description of the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is set to commence recruitment on February 15, 2024, with an estimated completion date of February 15, 2027. The trial is categorized under phase 9, indicating an advanced stage of clinical research. Although specific efficacy parameters such as primary and 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 trial's design will ensure that efficacy assessments are conducted systematically to provide reliable and scientifically valid results.