Allogenic stem cell transplantation in children and adolescents with acute lymphoblastic leukaemia

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1000

Inclusion Criteria

•All patients with ALL (except for patients with B-ALL) who fulfil the following criteria:
•age at time of screening 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: 100
F.1.2 Adults (18-64 years) yes
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

Exclusion Criteria

•Patients who do not fulfil the inclusion criteria
•Non Hodgkin-Lymphoma
•ALL with extramedullary involvement with indication for TBI
•CNS involvement at screening timepoint
•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 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;
Renal impairment (< 30% of normal glomerular filtration rate)
Severe pulmonary, hepatic or cardial impairment due to toxicity or infection
•Karnofsky / 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
Main Objective: Stratum 1: To show that a non TBI containing conditioning (Flu/Thio/ivBu OR Flu/Thio/Treo) results in a non inferior survival as compared to conditioning with TBI/Etoposide in children older than 4 years after haematopoetic stem cell transplantation (HSCT) from a HLA identical sibling donor (MSD) or a HLA matched donor (MD).<br>Stratum 2: To explore EFS after HSCT from HLA mismatched donors MMD) using mismatched unrelated donors , mismatched cord blood or HLA haplo-dentical family members with non TBI-conditioning regimen. <br>;Secondary Objective: not applicable;Primary end point(s): Stratum 1: OS<br>Stratum 2: EFS<br>;Timepoint(s) of evaluation of this end point: annually

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Treatment-related mortality<br>•Relapse incidence<br>•Toxicity: acute and late<br>•Acute GVHD and chronic GVHD<br>•Secondary malignancies<br>;Timepoint(s) of evaluation of this end point: annually

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