A clinical study of the use of teicoplanin in children with blood cancer to prevent infections
- Conditions
- Acute myeloid leukemiaMedDRA version: 20.0Level: LLTClassification code 10024346Term: Leukemia myeloblastic acuteSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-000508-13-NL
- Lead Sponsor
- Princess Máxima Center for Pediatric Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 130
Newly diagnosed with AML
Being registered and starting treatment according to the NOPHO-DBH AML 2012 study protocol, or a consecutive protocol
Age 0-19 years
Written informed consent by the patient and/or legal guardians (whatever applicable according to the patients age)
Are the trial subjects under 18? yes
Number of subjects for this age range: 130
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Acute promyelocytic leukemia
Secondary AML
Down Syndrome
Preexisting primary immunodeficiency
Patients who receive regular antibiotic prophylaxis against Gram-positive bacteria for other conditions than leukemia-related
Patients with a history of a severe allergic reaction (CTCAE grade =3) to teicoplanin and/or vancomycin
Patients with an eGFR of <30 ml/min/1.73m2 at the start of the study
Patients with a history of severe impaired hearing (CTCAE grade =3)
Pregnant or breast-feeding patients
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