EUCTR2021-003282-36-NO进行中（未招募）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. - SCRIPT-AM
Västra Götalands Regionen0 个研究点目标入组 230 人开始时间: 2022年4月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 230
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 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.
- •-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: 170
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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.
研究者
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