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Pharmacokinetics of anti-lymphocyte serum in the prevention of GvHD in children and adults receiving allogeneic hematopoietic stem cell transplantation - PHASAL-GA Study
EU CTIS ID: 2022-501594-39-00
What this study is testing
characterize the pharmacokinetics (PK) of anti-lymphocyte serum (SAL), Thymoglobulin® in patients involved in a HSC transplantation procedure
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient receiving Thymoglobulin therapy as part of a first HSC allograft
- Age ≥ 2 years
- Lansky or Karnosky score ≥ 50%.
- Enrolled in a social security plan
- Patient 18 years of age or older informed and consenting to participate in the study or minor patient whose parents/guardians have been informed and have given consent for the minor patient's participation in the study
- Patients of childbearing potential must have an effective method of contraception throughout the study (a pregnancy test will also be performed at inclusion). Examples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, male sterilisation, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices.
You likely can't join if
- Patient having received serotherapy (Thymoglobulin® or other) within 3 months before this HSC allograft
- 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)
See the full eligibility criteria
- Patient receiving Thymoglobulin therapy as part of a first HSC allograft
- Age ≥ 2 years
- Lansky or Karnosky score ≥ 50%.
- Enrolled in a social security plan
- Patient 18 years of age or older informed and consenting to participate in the study or minor patient whose parents/guardians have been informed and have given consent for the minor patient's participation in the study
- Patients of childbearing potential must have an effective method of contraception throughout the study (a pregnancy test will also be performed at inclusion). Examples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, male sterilisation, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices.
- Patient having received serotherapy (Thymoglobulin® or other) within 3 months before this HSC allograft
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.