Studying Conditioning Regimen In Pediatric Transplantation – AM

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 230

Inclusion Criteria

Inclusion criteria for randomization part of the study
- Age =18 years at time of initial AML, age = 21 years at transplantation.
-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
o < 5 % leukemic blasts confirmed by flow cytometry in a bone marrow sample taken =14 days prior to start of conditioning and
o no evidence of extramedullary disease, including in CNS and
o 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
o HLA 10/10 allelic matched, identical, sibling BM donor or
o HLA 10/10 or 9/10 allelic matched related/unrelated BM or PBSC donor or
o HLA 5-6/6 unrelated or 6-7-8/8 unrelated Cord Blood (UCB)
- HCT is performed in a study participating center.
7.2 Inclusion criteria for observation/registration only
- Diagnosis of Acute Myeloid Leukemia (AML).
- 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.
- HCT is performed in a study participating center.
- 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 215
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria for the randomization part of the study
Patients are excluded from the randomization part of the study if any of the criteria below are present:
- 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 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.
- 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

Exclusion criteria for the observational part of the study
Patients are excluded from the observational part of the study if any of the criteria below are present:
- Diagnosis of Myelodysplastic syndrome (MDS).
- Diagnosis of Juvenile myelomonocytic leukemia (JMML).
- Age above 21 years at time of transplantation
- No consent is given
- Prior autologous or allogeneic hematopoietic stem cell transplant.