Model-Informed Precision Dosing on Cyclosporine Therapy in Hematopoietic Stem Cell Transplant Recipients

Sponsor
Yasmin medhat munir Mohamed
Study ID
NCT07695571
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • AML
  • Bone Marrow Transplantation

Eligibility Criteria

Sex
ALL
Age
2 Years - 65 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jul 10, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Jan 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Patients receiving cyclosporine to prevent graft-versus-host disease after HSCT.
    Participants undergoing allogeneic hematopoietic stem cell transplantation who received cyclosporine for graft-versus-host disease (GVHD) prophylaxis. Cyclosporine was administered according to institutional practice, and blood concentration measurements obtained during routine therapeutic drug monitoring were used to develop and evaluate a model-informed precision dosing algorithm.

Primary Outcome Measure

Predictive accuracy of individualized cyclosporine dosing models. [ Time Frame: up to 6 months ]

Central Contacts

Find similar trials

Nationwide
Leukemia (other) trialsOncology trialsBlood cancer trials

Related Studies