Understanding Thymoglobulin use in stem cell transplantation
Thymoglobulin® Pharmacokinetics for Graft-versus Host Disease in Children and Adults Undergoing Hematopoietic Stem Cell Transplantation
This study is testing how well Thymoglobulin works to prevent graft-versus-host disease in patients getting stem cell transplants and aims to find the best dose for each person.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 2 sites (Lyon and 1 other locations) |
| Trial ID | NCT05743400 on ClinicalTrials.gov |
What this trial studies
This study investigates the pharmacokinetics of Thymoglobulin, a medication used to prevent graft-versus-host disease (GvHD) in patients undergoing hematopoietic stem cell transplantation (HSCT). The research aims to identify the relationships between drug exposure and response, which can vary significantly among patients. By analyzing these pharmacokinetic and pharmacodynamic parameters, the study seeks to optimize Thymoglobulin dosing to enhance clinical outcomes and minimize adverse effects. Participants will receive Thymoglobulin injections and undergo blood tests to monitor drug levels and effects.
Who should consider this trial
Good fit: Ideal candidates include patients aged 2 years and older receiving Thymoglobulin therapy as part of their first HSCT.
Not a fit: Patients who have received serotherapy within the last three months or have uncontrolled infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized Thymoglobulin dosing, improving patient outcomes in HSCT.
How similar studies have performed: Other studies have shown varying success with pharmacokinetic approaches in similar contexts, but this specific investigation into Thymoglobulin is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient receiving Thymoglobulin therapy as part of a first HSCT * Age ≥ 2 years * Lansky or karnofsky score ≥ 50%. * Enrolled in a social security plan * Patient 18 years of age or older who is informed and has consented to participate in the study or minor patient whose parents/guardians have been informed and have given consent for the minor patient to participate in the study * Female patients of childbearing potential must have an effective method of contraception (a pregnancy test will also be performed at inclusion). Exclusion Criteria: * Patient having received serotherapy (Thymoglobulin® or other) within 3 months before this HSCT * Patient receiving another serotherapy during conditioning (Campath®) * Patients with uncontrolled acute or chronic infections for which any form of immunosuppression would be contraindicated * Known hypersensitivity to Thymoglobulin®. * Pregnant or lactating women * Patient participating simultaneously in another study of an investigational drug (no exclusion period) * Patient under legal protection or deprived of liberty
Where this trial is running
Lyon and 1 other locations
- Institut d'Hématologie et d'Oncologie Pédiatrique — Lyon, France (Recruiting)
- Centre Hospitalier Lyon Sud — Pierre-Bénite, France (Recruiting)
Study contacts
- Study coordinator: Michael Philippe, MD, PhD
- Email: michael.philippe@lyon.unicancer.fr
- Phone: 0469166595
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.