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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501594-39-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental treatment arm | Experimental | Children over two years and adults undergoing a first hematopoietic stem cell transplantation will receiveThymoglobulin® as part of the conditioning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymoglobulin 25 milligrams (mg) Injection | Drug | Patients will receive thymoglobulin between 5 and 20 milligrams/kilograms (mg/kg) as an intravenous infusion over a period of 2 to 5 days depending on the dose and the transplant package chosen by the physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC) | Measure of the Thymoglobulin® exposure by the PK criteria : Area under the concentration-time curve (AUC) . AUC is measured by day since the first day of Thymoglobulin infusion during conditioning (day 0) until elimination tf the drug. AUC is expressed as milligrams/hour/Liter. (mg/h/L) | until elimination tf the drug (maximum 3 weeks post hematopoietic stem cell transplantation) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective function value (OFV) | Comparison of the OFV of different build population pharmacokinetic models based on results of pharmacokinetic analysis, from start of thymoglobulin® infusion until elimination of the drug | until elimination tf the drug (maximum 3 weeks post hematopoietic stem cell transplantation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Philippe, MD, PhD | Contact | 0469166595 | +33 | michael.philippe@lyon.unicancer.fr |
| Sylvain Goutelle, PU, PH | Contact | sylvain.goutelle@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut d'Hématologie et d'Oncologie Pédiatrique | Recruiting | Lyon | 69008 | France |
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| blood test | Biological | Thymoglobulin® serum levels Time frame : samples will be drawn at the following points :
|
|
| Coefficient of variation of AUC |
Ratio of typical variation of AUC to the mean AUC. AUC is measured by day since the first day of Thymoglobulin infusion during conditioning (day 0) until elimination of the drug |
| until elimination tf the drug (maximum 3 weeks post hematopoietic stem cell transplantation) |
| Centre Hospitalier Lyon Sud | Recruiting | Pierre-Bénite | 69495 | France |
|
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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