Comparing two preparation treatments before stem cell transplant in children with leukemia
Compares two conditioning drug regimens before stem cell transplant in children with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Studying Conditioning Regimen In Pediatric Transplantation - AML , SCRIPT-AML
Key facts
- Where
- Madrid, SpainSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
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 myeloid leukemia in remission who need a stem cell transplant from a donor. It compares two chemotherapy regimens given before the transplant.
- Age
- Age 18 years or younger at first AML diagnosis, and 21 years or younger at transplant.
- Sex
- All sexes can join.
- Disease stage
- Acute myeloid leukemia in remission (less than 5% leukemic blasts, no disease outside the bone marrow), either relapsed after first treatment or in first remission with a transplant indication.
- Earlier treatment
- Treated with a defined international AML protocol (NOPHO-DBH AML 2012 or new protocol). No earlier stem cell transplant.
- Biomarker or test result
- A related or unrelated donor is needed: HLA 10/10 sibling or related/unrelated donor, HLA 9/10 donor, or a compatible cord blood unit.
Main reasons for not taking part
- Myelodysplastic syndrome or juvenile myelomonocytic leukemia
- Earlier cancer, or known Fanconi anemia
- Earlier autologous or allogeneic stem cell transplant
- Uncontrolled infection or major organ failure
- Pregnant or breastfeeding
Read by machine on 12 November 2026.
Where in Spain
- Stemcelltransplant unit Hospital Niño JesúsMadrid, SpainContact: Marta Gonzales Vicent Gonzales Vicent, MD, PhDNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Vastra Gotaland Region
- Trial code
- NCT05477589
- Record updated
- 19 December 2024
- Original description
It is a randomized phase 3 study comparing two conditioning regimens in children with Acute Myeloid Leukemia, AML, undergoing allogenic stem cell transplantation. The primary aim is to investigate if a conditioning regimen containing one alkylator (Bu) combined with two antimetabolites (Clo and Flu) results in superior 2-year acute grade III to IV-free, chronic non-limited GvHD-free, relapse free survival than a conditioning regimen combining three alkylating agents (BuCyMel)Read full original descriptionShow less
A Randomized, Multi-Center Phase III Trial Comparing Two Conditioning Regimens (CloFluBu and BuCyMel) in Children With Acute Myeloid Leukemia Undergoing Allogeneic Stem Cell Transplantation.
It is a randomized phase 3 study comparing two conditioning regimens in children with Acute Myeloid Leukemia, AML, undergoing allogenic stem cell transplantation. The primary aim is to investigate if a conditioning regimen containing one alkylator (Bu) combined with two antimetabolites (Clo and Flu) results in superior 2-year acute grade III to IV-free, chronic non-limited GvHD-free, relapse free survival than a conditioning regimen combining three alkylating agents (BuCyMel)
Inclusion: Age ≤18 years at time of initial AML, age ≤ 21 years at transplantation; HCT is performed in a study participating center; All women of childbearing potential who have to have a negative pregnancy test within 2 weeks prior to the start of treatment; Signed informed consent; Any relapsed AML after initial treatment according to a defined international AML protocol. (NOPHO-DBH AML 2012/new protocol), or AML in first remission with transplant indications and treatment according to national AML protocol (NOPHO-DBH AML 2012 or new protocol); In hematological remission, defined as:; < 5 % leukemic blasts confirmed by flow cytometry (in patients with an informative leukemia associated immunophenotype) in a bone marrow sample taken ≤14 days prior to start of conditioning and no evidence of extramedullary disease, including in CNS and no leukemic blasts in the peripheral blood (verified by flow cytometry in case immature cells are detected in the peripheral blood differential); -Patients must have a related or unrelated donor fulfilling any of the following criteria: HLA 10/10 allelic matched, identical, sibling BM donor or HLA 10/10 or 9/10 allelic matched related/unrelated BM or PBSC donor orHLA 5-6/6 unrelated or 6-7-8/8 unrelated Cord Blood (UCB); Diagnosis of acute myeloid leukemia; Indication for allogeneic stem cell transplantation, as defined by primary treatment protocol or treating physician; Age ≤18 years at time of initial AML, age ≤ 21 years at transplantation; Not eligible for randomization, either due to lack of consent or not fulfilling inclusion criteria for interventional part of the study; Signed informed consent to prospectively register follow-up data.
Exclusion: Prior autologous or allogeneic hematopoietic stem cell transplant; Planned prophylactic DLI or other immunotherapeutic interventions after HCT that are not included in the upfront protocol, Planned anti-leukemic medication after HCT that are not included in the upfront protocol; Known intolerance to any of the chemotherapeutic drugs in the protocol; Patients with uncontrolled bacterial, viral, or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment; 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, renal impairment (<30% of normal glomerular filtration rate), severe pulmonary, hepatic or cardiac impairment due to toxicity or infection; Females of childbearing potential or men who have sexual contact with females of childbearing potential unwilling to use effective forms of birth control or abstinence for one year after transplantation; Prior autologous or allogeneic hematopoietic stem cell transplant; Diagnosis of myelodysplastic syndrome (MDS); History of previous malignancy (AML diagnosed as secondary cancer); Major organ failure precluding administration of planned chemotherapy; Diagnosis of Myelodysplastic syndrome (MDS); Females who are pregnant (positive serum or urine βHCG) or breastfeeding; Age above 21 years at time of transplantation; Diagnosis of juvenile myelomonocytic leukemia (JMML); Known diagnosis of Fanconi anemia; Karnofsky / Lansky score < 50%; Subjects unwilling or unable to comply with the study procedures; Diagnosis of Juvenile myelomonocytic leukemia (JMML); No consent is given to prospectively register outcome data.