Allogenic stem cell transplantation in children and adolescents with acute lymphoblastic leukaemia
- Conditions
- acute lymphoblastic leukaemiaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-003032-22-CZ
- Lead Sponsor
- St. Anna Kinderkrebsforschung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
Patients with ALL (except for patients with B-ALL)
who fulfil the following criteria:
•age at time of conditioning less than 18 years
•indication for allogeneic HSCT
•complete remission (CR) before SCT
•written consent of the parents (legal guardian) and, if necessary,
the minor patient via Informed Consent Form”
•no pregnancy
•no secondary malignancy
•no previous HSCT
•HSCT is performed in a study participating centre
Are the trial subjects under 18? yes
Number of subjects for this age range: 1000
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Patients who do not fulfil the inclusion criteria
•Non Hodgkin-Lymphoma
•Extramedullary Disease requiering TBI
•Trisomy 21
•The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
•No consent is given for saving and propagation of pseudonymized medical data for study reasons
•Severe concomitant disease that does not allow treatment according to the protocol at the investigator’s discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
•Karnovsky / Lansky score < 50%
•Subjects unwilling or unable to comply with the study procedures
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