EUCTR2017-004800-23-GB进行中（未招募）1 期
A comparison of reduced dose total body irradiation (TBI) and cyclophosphamide with fludarabine and melphalan reduced intensity conditioning in adults with acute lymphoblastic leukaemia (ALL) in complete remission. - ALL-RIC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 242
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
- •Patients with morphologically documented ALL who meet the following criteria;
- •Patients between the ages of 40-65 years. NB: Patients under the age of 40 who are considered unsuitable for a myeloablative transplant may enrol onto the trial following discussion with the CI via the Trials Office
- •Patients with ALL in first CR
- •Availability of a human leukocyte antigen (HLA) identical sibling or suitable matched unrelated donor (suitable matched defined as no greater than a single allele mismatch at HLA A, B, C or DRß1). A single allele mismatch is permitted if there are adverse cytogenetics or MRD positivity at any timepoint
- •Patients considered suitable to undergo a RIC allogeneic SCT as clinically judged by the Local Investigator including:-
- •o Adequate hepatic and renal function as determined by full blood count and biochemistry assessment
- •o Resolution of any toxic effects of prior therapy (including radiotherapy, chemotherapy or surgical procedures). Patients with bone marrow suppression following therapy may enter the trial
- •o Patients with abnormal cardiac and/or pulmonary function must be considered fit for allogeneic SCT including 8Gy of TBI at the time of randomisation.
- •Patients with an ECOG performance status 0,1 or 2
- •Female of and male patients of reproductive potential(i.e. not post-menopausal or surgically sterilised) must use appropriate, highly effective, contraception from the point of admission for transplant conditioning therapy until 12 months after transplant
- •Patients have given written informed consent
- •Patients willing and able to comply with scheduled study visits and laboratory tests
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients with contraindications to receiving RIC allogeneic SCT
- •Female patients who are pregnant or breastfeeding. All women of childbearing potential (WOCBP) must have a negative pregnancy test before commencing treatment
- •Adults of reproductive potential not willing to use appropriate, effective, contraception during the specified period
- •Patients with renal or hepatic impairment as clinically judged by Local Investigator
- •Patients with active infection, HIV-positive or chronic active Hep-A or –C
- •Patients with concurrent active malignancy. Patients with a previous history of malignancy can be included if that malignancy is considered to be at a low risk of recurrence
研究者
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