Study protocol for acute myeloid leukemia in children and adolescent
- Conditions
- pediatric patient with acute myeloid leukemiaMedDRA version: 17.0Level: LLTClassification code 10024349Term: Leukemia myeloidSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-000652-28-IT
- Lead Sponsor
- A.I.E.O.P.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Patients with LAM
Patients aged between 0 and 18 years (17 years and 364 days) at diagnosis.
Signed informed consent from the parents, or the legal representative of the child with the disease leukemia.
Are the trial subjects under 18? yes
Number of subjects for this age range: 300
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Down Syndrome
Acute Promyelocytic leukemia (FAB M3) or t (15; 17) rearrangement with PML / RARa (Treatment Protocol ad hoc)
AML secondary to MDS
T-AML (therapy-related AML)
Pregnancy or lactation in progress
Pretreatment with anticancer or treatment with steroid drugs more than 7 days
Organ dysfunctions
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