TREOSULFAN LEVELS IN CHILDREN UNDERGOING STEM CELL TRANSPLANTATIO
- Conditions
- Any paediatric disease with an indication to an allogeneic stem cell transplantation (inclusing leukaemia, primary immunodeficiencies, metabolic disorders and autoimmune or genetic inflammatory bowel disorders).Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2013-003257-20-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 90
Patients affected by malignant or non-malignant diseases with an indication to allogeneic HSCT.
Patients must meet all of the following criteria for admission in the study:
1) age = 28 days and = 18 years old;
2) Karnofsky Performance Status = 50 or Lansky Performance Status = 30;
3) provide signed, written informed consent from parent or guardian;
4) be able to comply with study procedures and follow-up examinations;
5) have adequate organ function (as indicated by Table 1, page 27), within 14 days prior enrollment;
6) negative pregnancy test in post-pubertal female patients.
Are the trial subjects under 18? yes
Number of subjects for this age range: 90
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Patients who meet any of the following criteria will be excluded from study admission:
1)Patients aged < 28 days and > 18 years old;
2)patients with compromised organ function*;
3)patients with any other severe concurrent disease, which, in the judgment of the Investigator, would make the patient inappropriate for entry into this study;
4)Known hypersensitivity to Treosulfan or Fludarabine;
5)Pregnancy/lactation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method