Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia

• Status: Recruiting
• Trial end date: 2026-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen.

The stratification of patients in first and following remissions according to the individual transplantation modalities rests upon an indication for allogeneic HSCT and the availability of a suitable donor within the individual transplantation groups.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Anna Kinderkrebsforschung
• Collaborators: ALL SCTped Forum; ALL-BFM Study Group; Assistance Publique - Hôpitaux de Paris; Australian & New Zealand Children's Haematology/Oncology Group; Dutch Childhood Oncology Group; European Society for Blood and Marrow Transplantation; Swiss Pediatric Oncology Group
• Treatments: Antilymphocyte Serum; Busulfan; Cyclophosphamide; Etoposide; Fludarabine; Immunoglobulins; Thiotepa; Thymoglobulin; Treosulfan

Criteria

Inclusion Criteria:

Patients with ALL (except for patients with B-ALL) who fulfil the following criteria:

• age at diagnosis ≤ 18 years. Age at HSCT ≤ 21 years

• indication for allogeneic HSCT

• complete remission (CR) before HSCT

• 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

Exclusion Criteria:

• 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