Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18 - 18
Clinical summary
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).
Conditions
This trial is treating people with Acute Lymphoblastic Leukaemia
Eligibility
Inclusion
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
- 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
Inclusion
- You have had a certain type of treatment or surgical procedure.
Exclusion
- 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, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
St. Anna Kinderkrebsforschung
Scientific Title
Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
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