EUCTR2019-002419-24-GB进行中（未招募）1 期
A multi-centre phase II trial of GvHD prophylaxis following unrelated donor stem cell transplantation comparing Thymoglobulin vs. Calcineurin inhibitor or Sirolimus-based post-transplant cyclophosphamide - MoTD
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
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
- •Availability of suitably matched unrelated donor (9/10 or 10/10)
- •Planned to receive one of the following reduced intensity conditioning(RIC)
- •o Fludarabine-melphalan (Fludarabine 120-180mg/m^2; melphalan = 150mg/m^2)
- •o BEAM or LEAM (carmustine 300mg/m^2 or lomustine 200mg/m^2 with: etoposide 800 mg/m^2; cytarabine 1600mg/m^2; melphalan 140mg/m^2)
- •o Fludarabine-busulphan (Fludarabine 120-180mg/m^2; Busulphan = 8mg/kg PO or 6.4mg/kg IV)
- •Planned use of peripheral blood stem cells (PBSCs) for transplantation
- •Planned allo-SCT for one of the following haematological malignancies:
- •o AML in complete remission (CR)
- •o ALL in CR
- •o CMML <10% blasts
- •o MDS <10% blasts
- •o NHL in CR/partial remission (PR)
- •o HL in CR/PR
- •o MM in CR/PR
- •o CLL in CR/PR
- •o CML in 1st or 2nd chronic phase
- •o Myelofibrosis
- •Age 16-70 years
- •Females of and male patients of reproductive potential (i.e., not post-menopausal or surgically sterilised) must agree to use appropriate, highly effective, contraception from the point of commencing therapy until 12 months after transplant
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 320
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Use of any method of graft manipulation (excluding storage of future donor lymphocyte infusion)
- •Use of alemtuzumab or any method of T cell depletion except those that are protocol-defined
- •Known hypersensitivity to study drugs or history of hypersensitivity to rabbits
- •Pregnant or lactating women
- •Adults of reproductive potential not willing to use appropriate, highly effective, contraception during the specified period
- •Life expectancy <8 weeks
- •Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection
- •Organ dysfunction defined as:
- •o left ventricular ejection fraction (LVEF) <45%
- •o Glomerular filtration rate (GFR) <50ml/min
- •o Bilirubin >50µmol/l
- •o Aspartate transaminase (AST) or alanine transferase (ALT) >3 x upper limit of normal (ULN)
- •Participation in COSI or ALL-RIC trials
研究者
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