ISRCTN50855000已完成2 期
A randomised trial of the FLAMSA-BU conditioning regimen in patients with acute myeloid leukaemia and myelodysplasia undergoing allogeneic stem cell transplantation
niversity of Birmingham (UK)0 个研究点目标入组 244 人开始时间: 2013年10月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 244
研究概览
简要总结
2019 Abstract results in https://doi.org/10.1182/blood-2019-125646 Presented at ASH (added 12/05/2022) 2021 Results article in https://dx.doi.org/10.1200/JCO.20.02308 (added 12/05/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with a morphologically documented diagnosis of AML or MDS clinically indicated to receive a RIC allograft with one the following disease characteristics:
- •1.1. Patients in 1st complete remission (CR1) with adverse risk cytogenetics
- •1.2. Patients in 2nd complete remission (CR2)
- •1.3. Patients with primary refractory AML defined as the failure to achieve a morphological remission after 2 courses of induction chemotherapy
- •1.4. Patients participating in the UK NCRN AML17 (or the subsequent AML19) clinical trial who have been defined as high risk (based upon age, de novo or secondary disease, cytogenetics, white blood count, sex and response to course 1)
- •1.5. Patients participating in the UK NCRN AML17, AML18 (or the subsequent AML19) clinical trials who have been defined as high risk by Minimal Residual Disease (MRD) criteria
- •1.6. Patients with advanced MDS (defined by an IPSS score of INT1 with >5% blasts or INT2 or high risk ) who have < 5% blasts at the time of randomisation following chemotherapy or hypomethylating agents if necessary
- •2. Patients aged = 16 years
- •3. Patients with an HLA identical sibling or suitable matched unrelated donor (suitable match defined as no greater
- •than a single allele mismatch at HLA A, B, C or DRB1)
- •4. Patients considered suitable to undergo a reduced intensity conditioned allogeneic stem cell transplant as clinically judged by the Local Investigator including:
- •4.1. Adequate cardiac, pulmonary, hepatic and renal function as determined by pre-transplant assessments
- •4.2. Resolution of any toxic effects of prior therapy (including radiotherapy, chemotherapy or surgical procedures)
- •5. Patients with an ECOG performance status of 0, 1 or 2
- •6. Patients have given written informed consent
- •7. Patients willing and able to comply with scheduled study visits and laboratory tests
排除标准
- •1. Patients with chemorefractory relapse of AML or MDS
- •2. Patients with contraindications to receiving RIC allogeneic SCT
- •3. Female patients who are pregnant or breastfeeding. All women of childbearing potential must have a negative pregnancy test before commencing treatment
- •4. Adults of reproductive potential not willing to use appropriate, effective, contraception during the specified period
- •5. Patients with clinically significant cardiac disease (New York Heart Association, Class III or IV)
- •6. Patients with renal or hepatic impairment as clinically judged by Local Investigator
- •7. Patients with active infection, HIV positive or chronic active Hep A, B, C
- •8. Patients with concurrent active malignancy
研究者
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