Actively Recruiting
Thymoglobulin® Pharmacokinetics in Patients Undergoing Hematopoietic Stem Cell Transplantation
Led by Hospices Civils de Lyon · Updated on 2024-09-19
35
Participants Needed
2
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Thymoglobulin is widely applied as serotherapy in order to prevent acute graft-versus-host disease (GvHD) and graft rejection in patients undergoing non-Human Leukocyte Antigen (HLA)-identical hematopoietic stem cell transplantations (HSCT), with a delicate balance between prevention of GvHD and the promotion of immune reconstitution. Thymoglobulin is known as a drug with high pharmacokinetic (PK) variability. This variability influences drug exposure, which in turn determines the drug response of pharmacodynamics (PD). In order to maintain efficacy while reducing adverse effects of drugs across the entire age range, identification of the PK/PD relationships and the effect of growth and maturation on the different PK and PD parameters involved are crucial. The investigators hypothesise that a better knowledge of Thymoglobulin PK and its covariates would help to individualise dosage regimen and would improve clinical outcomes, such as GvHD and immune reconstitution. The investigators aim to build a population PK model of Thymoglobulin in order to study PK variability and its covariates. This model will help in optimizing dosage regimen in an individually way.
CONDITIONS
Official Title
Thymoglobulin® Pharmacokinetics in Patients Undergoing Hematopoietic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient receiving Thymoglobulin therapy as part of a first HSCT
- Age 65 2 years
- Lansky or Karnofsky score 65 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).
You will not qualify if you...
- Patient having received serotherapy (Thymoglobulin4 or other) within 3 months before this HSCT
- Patient receiving another serotherapy during conditioning (Campath4)
- Patients with uncontrolled acute or chronic infections for which any form of immunosuppression would be contraindicated
- Known hypersensitivity to Thymoglobulin4
- 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
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Institut d'Hématologie et d'Oncologie Pédiatrique
Lyon, France, 69008
Actively Recruiting
2
Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69495
Actively Recruiting
Research Team
M
Michael Philippe, MD, PhD
CONTACT
S
Sylvain Goutelle, PU, PH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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