ISRCTN99927695进行中（未招募）2 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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 102
研究概览
简要总结
2023 Protocol article in https://doi.org/10.1136/bmjopen-2022-067790 (added 02/06/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patients with morphologically documented ALL who meet the following criteria;
- •1. 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
- •2. Patients with ALL in first CR
- •3. 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
- •4. Patients considered suitable to undergo a RIC allogeneic SCT as clinically judged by the Local Investigator including:
- •4.1. Adequate hepatic and renal function as determined by full blood count and biochemistry assessment
- •4.2. 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
- •4.3. Patients with abnormal cardiac and/or pulmonary function must be considered fit for allogeneic SCT including 8Gy of TBI at the time of randomisation.
- •5. Patients with an ECOG performance status 0,1 or 2
- •6. 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
- •7. Patients have given written informed consent
- •8. Patients willing and able to comply with scheduled study visits and laboratory tests
排除标准
- •1. Patients with contraindications to receiving RIC allogeneic SCT
- •2. Female patients who are pregnant or breastfeeding. All women of childbearing potential (WOCBP) must have a negative pregnancy test before commencing treatment
- •3. Adults of reproductive potential not willing to use appropriate, effective, contraception during the specified period
- •4. Patients with renal or hepatic impairment as clinically judged by Local Investigator
- •5. Patients with active infection, HIV-positive or chronic active Hep-A or -C
- •6. 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
相似试验
进行中（未招募）
1 期
A comparison of two low-intensity transplant regimens for the treatment of adults with acute lymphoblastic leukaemia (ALL) over the age of 40 years (ALL-RIC)Acute Lymphoblastic Leukaemia (ALL)MedDRA version: 20.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 100000004864EUCTR2017-004800-23-GBniversity of Birmingham242
已完成
2 期
Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell TransplantationMyelodysplastic SyndromesMyeloproliferative DisorderAcute Myeloid LeukemiaChronic Lymphocytic LeukemiaT-cell LymphomaNon Hodgkin LymphomaB-cell LymphomaHodgkin LymphomaChronic Myelomonocytic LeukemiaNCT03734601Stanford University22
已完成
不适用
APHRODITE - A phase II trial of higher radiotherapy dose in the eradication of early rectal cancerColorectal cancerCancerISRCTN16158514niversity of Leeds104
进行中（未招募）
不适用
MR-guided adaptive stereotactic radiotherapy in localised pancreatic cancerocally advanced pancreatic cancerMalignant neoplasm of pancreasCancerISRCTN10557832niversity of Oxford25
进行中（未招募）
2 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)Acute Lymphoblastic LeukemiaNCT03821610University of Birmingham242