Allogeneic stem cell transplantation in children and adolescents with acute lymphoblastic leukemia - ALL SCT BFM International

Conditions: children and adolescents less than 18 years old with the diagnosis ALL in first or any following remission with high risk of recurrence of their leukemia
MedDRA version: 6.1Level: SOCClassification code 10005329

Registration Number: EUCTR2005-005106-23-IT

Lead Sponsor: ST. ANNA KINDERSPITA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 405

Inclusion Criteria

patients with ALL (except for patients with B-ALL) who fulfil the following criteria: age at time of initial diagnosis or relapse diagnosis, respectively ≤18 years indication for allogeneic HSCT complete remission (CR) is achieved before SCT written consent of the parents (legal guardian) and, if indicated, 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:
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

Exclusion Criteria

gravidanza presunta o accertata diagnosi di seconda neoplasia maligna precedente TCSE

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate whether HSCT from matched family or unrelated donors(MD) is equivalent to the HSCT from matched sibling donors (MSD);Secondary Objective: To evaluate the efficacy of HSCT from mismatched family or unrelated donors (MMD) as compared to HSCT from MSD/MD. To determine whether therapy has been carried out according to the main HSCT protocol recommendations. The standardisation of the treatment options during HSCT from different donor types aims at the achievement of an optimal comparison of survival after HSCT with survival after chemotherapy only. To prospectively evaluate and compare the incidence of acute and chronic GvHD after HSCT from MSD, from MD and from MMD.;Primary end point(s): Primary endpoint: event-free and overall survival after allogeneic HSCT, occurrence of acute and chronic Graft-versus-Host-Disease (GvHD), occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT

Secondary Outcome Measures