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New treatment option for Acute Myeloid Leukemia (AML) in Remission
Official title Studying Conditioning Regimen In Pediatric Transplantation - AML , SCRIPT-AML
ClinicalTrials.gov ID: NCT05477589
What this study is testing
What is busulfan, cyclophosphamide and melphalan, BuCyMel?
busulfan, cyclophosphamide and melphalan, BuCyMel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia (aml) in remission.
Also referred to as BuCyMel.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 18
You may be able to join if
- for randomization part of the study:
- 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.
You likely can't join if
- for the randomization part of the study :
- Diagnosis of myelodysplastic syndrome (MDS).
- Diagnosis of juvenile myelomonocytic leukemia (JMML).
- History of previous malignancy (AML diagnosed as secondary cancer).
- Known diagnosis of Fanconi anemia.
- Prior autologous or allogeneic hematopoietic stem cell transplant.
See the full eligibility criteria
- for randomization part of the study:
- 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...
- 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...
- 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 for treatment part of the study.
- Signed informed consent to prospectively register follow-up data.
- for the randomization part of the study :
- Diagnosis of myelodysplastic syndrome (MDS).
- Diagnosis of juvenile myelomonocytic leukemia (JMML).
- History of previous malignancy (AML diagnosed as secondary cancer).
- Known diagnosis of Fanconi anemia.
- 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.
- Major organ failure precluding administration of planned chemotherapy.
- 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...
- Karnofsky / Lansky score \< 50%
- Females who are pregnant (positive serum or urine βHCG) or breastfeeding.
- 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.
- people unwilling or unable to comply with the study procedures. Exclusion criteria for the observational part of the study:
- Diagnosis of Myelodysplastic syndrome (MDS).
- Diagnosis of Juvenile myelomonocytic leukemia (JMML).
- Age above 21 years at time of transplantation
- No consent is given to prospectively register outcome data
- Prior autologous or allogeneic hematopoietic stem cell transplant.
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Liège, Belgium
- Copenhagen, Denmark
- Helsinki, Finland
- Hong Kong, Hong Kong
- Petah Tikva, Israel
- Vilnius, Lithuania
- Utrecht, Netherlands
- Oslo, Norway
- Madrid, Spain
- Gothenburg, Sweden
- Lund, Sweden
- Stockholm, Sweden
- Uppsala, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium; Ghent, Belgium; Leuven, Belgium; Liège, Belgium; Copenhagen, Denmark; Helsinki, Finland and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.