NL-OMON53923尚未招募3 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 Götaland Regionen0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
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 64（—）
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.
- •HCT is performed in a study participating center
- •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 patients with an
- •informative leukemia associated immunophenotype) 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).
- •Inclusion criteria for observation/registration only:
- •Diagnosis of acute myeloid leukemia
- •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.
- •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.
排除标准
- •Exclusion criteria for randomization part of the study:
- •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 immunotherapeutic 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 βHCG) or breastfeeding.
- •Females of childbearing potential or men who have sexual contact with females
- •of childbearing potential 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 observation/registration only:
- •Diagnosis of Myelodysplastic syndrome (MDS).
- •Diagnosis of Juvenile myelomonocytic leukemia (JMML).
- •Age above 21 years at time of transplantation
- •No consent is given to prospectively register outcome data
- •Prior autologous or allogeneic hematopoietic stem cell transplant.
研究者
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