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Studying Conditioning Regimen In Pediatric Transplantation -AML
EU CTIS ID: 2023-505512-37-00
What this study is testing
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 (GRFS) than a conditioning regimen combining three alkylating agents (BuCyMel).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Inclusion criteria for randomization part of the study -Age ≤18 years at time of initial AML, age ≤ 21 years at transplantation.
- - In hematological remission, defined as
- -no evidence of extramedullary disease, including in CNS
- • < 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
- -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 :
You likely can't join if
- Exclusion criteria for the randomization part of the study; - Diagnosis of Myelodysplastic syndrome (MDS).
- - 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
- - Karnofsky / Lansky score < 50%
- - Females who are pregnant (positive serum or urine βHCG) or breastfeeding.
- - Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use effective forms of birth control or abstinence for one year after transplantation
See the full eligibility criteria
- Inclusion criteria for randomization part of the study -Age ≤18 years at time of initial AML, age ≤ 21 years at transplantation.
- - In hematological remission, defined as
- -no evidence of extramedullary disease, including in CNS
- • < 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
- -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
- -HLA 10/10 or 9/10 allelic matched related/unrelated BM or PBSC donor or
- -7.2 Inclusion criteria for observation/registration only
- -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).
- Exclusion criteria for the randomization part of the study; - Diagnosis of Myelodysplastic syndrome (MDS).
- - 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
- - Karnofsky / Lansky score < 50%
- - Females who are pregnant (positive serum or urine βHCG) or breastfeeding.
- - Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use effective forms of birth control or abstinence for one year after transplantation
- - Subjects unwilling or unable to comply with the study procedures
- - 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 immunotherapy 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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Israel
- Chile
- Hong Kong
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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Israel; Chile; Hong Kong. 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 EU CTIS; the study team decides eligibility.