Allogeneic Stem Cell Transplantation (SCT) for children and adolescents with acute lymphoblastic Leukaemia (ALL)
- Conditions
- cancer of the bloodleukaemia10024324
- Registration Number
- NL-OMON54836
- Lead Sponsor
- St, Anna Kinderkrebsforschung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 35
Patients with ALL (except for patients with mature B-ALL) who fulfil the
following criteria:
• Age at diagnosis <= 18 years or age at HSCT <= 21 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
• Patients who do not fulfil the inclusion criteria
• Non Hodgkin-Lymphoma
• 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 anonymous 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)
• Karnofsky / Lansky score < 50%
• Subjects unwilling or unable to comply with the study procedures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Stratum 1: Overall Survival (OS)<br /><br>Stratum 2: Event Free Survival (EFS)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Stratum 1: EFS<br /><br>Stratum 2: OS<br /><br><br /><br>Stratum 1 and 2:<br /><br>• Cumulative Incidence of Treatment-related mortality (TRM)<br /><br>• Cumulative Incidence of Relapse<br /><br>• Toxicity: acute and late<br /><br>• Acute Graft versus Host Disease (aGVHD) and chronic GVHD (cGvHD)<br /><br>• Secondary malignancies</p><br>