CTIS2023-505512-37-00招募中1 期
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 个研究点目标入组 103 人开始时间: 2023年10月4日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 103
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •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).
排除标准
- •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.
研究者
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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.Acute Myeloid Leukemia (AML)blood cancer10024324NL-OMON53923Västra Götaland Regionen30