CTIS2023-505512-37-00
Recruiting
Phase 1
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.
Vaestra Goetalandsregionen0 sites103 target enrollmentOctober 4, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Vaestra Goetalandsregionen
- Enrollment
- 103
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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
- •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 ßHCG) 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.
Outcomes
Primary Outcomes
Not specified
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