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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age1-18
SponsorSt. Anna Kinderkrebsforschung

About this trial

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.

Eligibility criteria

Qualifiers

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"

Disqualifiers

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

Trial design

Treatments tested in this trial

  • VP16
  • TBI
  • Thiotepa
  • Treosulfan
  • Fludarabine
  • Busulfan
  • ATG Thymoglobulin
  • Cyclophosphamide
  • Grafalon

Treatment groups

1,800 Participants
are divided into 4 treatment groups

Sponsors and collaborators

St. Anna Kinderkrebsforschung

Lead sponsor

St. Anna Kinderspital, Austria

Sponsor institution

ALL SCTped Forum

Collaborator

European Society for Blood and Marrow Transplantation

Collaborator

ALL-BFM Study Group

Collaborator

Assistance Publique - Hôpitaux de Paris

Collaborator

Dutch Childhood Oncology Group

Collaborator

Swiss Pediatric Oncology Group

Collaborator

Australian & New Zealand Children's Haematology/Oncology Group

Collaborator