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Stem cell transplantation for children and adolescents with acute lymphoblastic leukaemia

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

Phase2; Phase3 Interventional St. Anna Kinderkrebsforschung · NCT01949129

This study is testing if using chemotherapy instead of total body radiation before stem cell transplants can help children and teens with acute lymphoblastic leukaemia who are in remission, while also reducing side effects.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment1800 (estimated)
Ages1 Month to 18 Years
SexAll
SponsorSt. Anna Kinderkrebsforschung Academic / other
Drugs / interventionschemotherapy, fludarabine
Locations119 sites (Buenos Aires and 118 other locations)
Trial IDNCT01949129 on ClinicalTrials.gov

What this trial studies

This trial investigates the effectiveness of allogeneic stem cell transplantation (HSCT) in children and adolescents diagnosed with acute lymphoblastic leukaemia (ALL) who are in complete remission. The study aims to determine if a chemotherapy-based conditioning regimen can replace total body irradiation (TBI) before HSCT, potentially reducing late complications associated with TBI. It is a multinational, multicenter, controlled, prospective study that involves stratifying patients based on their individual transplantation modalities and donor availability. The trial seeks to gather data from a diverse patient population to improve treatment outcomes for those with high-risk ALL.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 21 years or younger with acute lymphoblastic leukaemia in complete remission who require allogeneic HSCT.

Not a fit: Patients with non-Hodgkin lymphoma or those who do not meet the inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols for pediatric ALL, reducing the risk of late complications associated with traditional TBI.

How similar studies have performed: Other studies have shown promise in using chemotherapy-based conditioning regimens, but this specific approach in pediatric ALL is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Buenos Aires and 118 other locations

+69 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Lymphoblastic Leukaemiastem cell transplantationchildren and adolescentshigh risk acute lymphoblastic leukaemia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.