OncoMatch/Clinical Trials/NCT05477589
Studying Conditioning Regimen In Pediatric Transplantation - AML , SCRIPT-AML
Is NCT05477589 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including busulfan, cyclophosphamide and melphalan, BuCyMel and clofarabine, fludarabine and busulfan, CloFluBu for acute myeloid leukemia (aml) in remission.
Treatment: busulfan, cyclophosphamide and melphalan, BuCyMel · clofarabine, fludarabine and busulfan, CloFluBu — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Disease stage
Required: Stage REMISSION
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).
Prior therapy
Cannot have received: autologous or allogeneic hematopoietic stem cell transplant
Prior autologous or allogeneic hematopoietic stem cell transplant
Lab requirements
Kidney function
renal impairment (<30% of normal glomerular filtration rate) [excluded]
Cardiac function
severe cardiac impairment due to toxicity or infection [excluded]; cardiac malformations [excluded]
severe pulmonary, hepatic or cardiac impairment due to toxicity or infection; cardiac malformations; renal impairment (<30% of normal glomerular filtration rate)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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