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NCT07695571
Model-Informed Precision Dosing on Cyclosporine Therapy in Hematopoietic Stem Cell Transplant Recipients
Conditions: Bone Marrow Transplantation, AML
Sex: All
Ages: 2 Years – 65 Years
Healthy volunteers: No
Enrollment: 300
Sponsor: Yasmin medhat munir Mohamed
Summary
The purpose of this study is to develop a new tool that helps doctors choose the right cyclosporine dose for patients undergoing bone marrow transplantation. The tool is designed to predict the best dose using sparse sampling, making it practical for everyday clinical care. It combines information about population pharmacokinetics of cyclosporine with advanced artificial intelligence techniques, including machine learning and deep learning. This tool aims to improve treatment, personalize dosing for each patient, and reduce the risk of graft-versus-host disease.
Eligibility Criteria
Inclusion Criteria:
* • CsA therapy indicated alone or in combination for GVHD prophylaxis.
* Aged 2-65 years.
* Clinically stable after first HSCT.
Exclusion Criteria:
* • Inaccurate sampling or dose administration times.
* Patients with missing key covariates.
* Patients lacking sufficient pharmacokinetic or TDM data
Source: ClinicalTrials.gov (NCT07695571). StuddyBuddy aggregates publicly available trial information.