InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

Closed (no longer recruiting)Last updated: 17 May 2024

FORUM: This phase II/III trial is evaluating allogenic stem cell transplatation as an optimal therapy for children and adolescents diagnosed with Acute Lymphoblastic Leukaemia (ALL)Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia

Clinical summary


Acute and late side effects of TBI in combination with other chemotherapeutic are manifold to the growing organism and include severe organ dysfunction/failure due to toxicity. Although transplant associated mortality was reduced after HSCT in the last decade due to better HLA matching, infection prevention and control, the burden of late complications is still a matter of concern.Growth retardation, hormonal dysfunction, sterility and the risk of secondary cancer are the late consequences of TBI in children.However, so far no prospective study has demonstrated similar outcomes in paediatric ALL using chemo-conditioning regimen before HSCT.The reason for that are manifold: only a minority of children with ALL qualify for allogeneic HSCT as most patients are cured with modern chemotherapy approaches alone. Those with dismal prognosis are treated in HSCT centres that care for patients with different diseases. Therefore it is nearly impossible to answer complex outcome questions in single centres or even in single countries. International cooperation are essential to allow prospective randomized investigation within comparable patient cohorts. This study aims to explore the efficacy and efficiency of two different chemo-conditioning regimens (Flu/Thio with Treo or ivBu) in comparison to the standard conditioning regimen (TBI/VP16). All patients with an indication for HSCT, age > 4 years and a matched donor (MD) or matched sibling donor (MSD) undergo randomisation between these two conditionings. The decision if the irradiation free conditioning is Flu/Thio/Treo or Flu/Thio/ivBu is stratified by country. Patients with age <4 years receive automatically the irradiation free conditioning. Patients with a mismatched donor are stratified according to the donor's stem cell source (cordblood, haploidentical tx or bone marrow/peripheral blood stem cells).


This trial is treating patients with Acute Lymphoblastic Leukaemia


Blood Cancers Haematological


People18 - 18



Trial Acronym


More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

St. Anna Kinderkrebsforschung

Scientific Title

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



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


  • 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


  • You have had a certain type of treatment or surgical procedure.


  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

+ Show non-recruiting hospitals

Closed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support


Cancer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Learn more


Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more


Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.


Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.