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Taking peoplePhase 2/3

Stem cell transplant for children and teens with acute lymphoblastic leukaemia

Tests stem cell transplants with different conditioning drugs in young patients with leukaemia.

Key facts

Who runs it
St. Anna Kinderkrebsforschung
Where
Graz, Innsbruck, and Vienna, AustriaSee the 3 sitesAlso in 30 other countries, 107 sites
Registry title
Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
Status
Recruiting
Phase
Phase 2/3
People taking part
1,800 people, planned
Started
Apr 2013
Expected to end
1 Jun 2030
Type of study
Interventional, 4 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • VP16
  • TBI
  • Thiotepa
  • Treosulfan
  • Fludarabine
  • Busulfan
  • ATG Thymoglobulin
  • Cyclophosphamide
  • Grafalon
Record updated
4 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and young people with acute lymphoblastic leukaemia (ALL), other than B-ALL, who are in complete remission and need an allogeneic stem cell transplant.

Age
Age at diagnosis 18 years or younger. Age at transplant 21 years or younger. The registry lists 1 Month to 18 Years.
Sex
All sexes can join.
Disease stage
ALL, except B-ALL. In complete remission before the transplant. An allogeneic stem cell transplant is needed.
Earlier treatment
No previous stem cell transplant.

Main reasons for not taking part

  • Pregnancy
  • Another cancer after the leukaemia (secondary malignancy)
  • A previous stem cell transplant
  • Non Hodgkin-Lymphoma
  • Severe other disease that does not allow treatment as in the protocol, or Karnofsky / Lansky score below 50%

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • 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
  • Karnofsky / Lansky score < 50%
  • subjects unwilling or unable to comply with the study procedures

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • What type of cancer has the patient been diagnosed with?
  • Has the patient had a stem cell transplant (a transplant of blood-forming cells from a donor or from their own body)?
  • Is the patient pregnant or breastfeeding?

Where in Austria

Also in 30 other countries, 107 sites

  • Medical University of GrazGraz, AustriaNo longer taking part
  • Medizinische Universitaet InnsbruckInnsbruck, AustriaNo longer taking part
  • St. Anna Kinderspital GmbHVienna, AustriaNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 4 groups in the trial

  • Flu/Thio/TreoTreatment being tested

    Fludarabine/Thiotepa/Treosulfan is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients with: * MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon. * MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon. * MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide

    Treatment: Thiotepa, Treosulfan, Fludarabine, ATG Thymoglobulin, and Grafalon

  • TBI/VP16Existing treatment, for comparison

    TBI (Total Body Irradiation) / VP16 is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients older than 48 months with: * MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon. * MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon. * MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide. Patients aged 24-48 months may optionally receive Total Body Irradiation (TBI).

    Treatment: VP16, TBI, ATG Thymoglobulin, and Grafalon

  • Flu/Thio/ivBuTreatment being tested

    Fludarabine/Thiotepa/iV Busulfan is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients with: * MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon. * MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon. * MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide

    Treatment: Thiotepa, Fludarabine, Busulfan, ATG Thymoglobulin, Cyclophosphamide, and Grafalon

  • Bu/VP16/CyTreatment being tested

    Busulfan/VP16/Cyclophosphamide is an alternative conditioning arm that may optionally be used for HSCT with MSD/MD and MMD graft in patients aged 0-24 months. Patients undergoing MD HSCT will also receive ATG Thymo- or Grafalon.

    Treatment: VP16, Busulfan, and Cyclophosphamide

Results explained

Papers that name this trial, each explained in plain words.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
Plain-language title
Stem cell transplant for children and teens with acute lymphoblastic leukaemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT01949129, who can take part
Publications
Record updated
4 September 2026