ISRCTN50290131进行中（未招募）2 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
适应症
试验速览
- 阶段
- 2 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
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 29/08/2023:
- •1. Availability of suitably matched unrelated donor (9/10 or 10/10)
- •2. Planned to receive one of the following reduced-intensity conditioning (RIC) protocols:
- •2.1. Fludarabine-melphalan (fludarabine 120-180 mg/m²; melphalan =150 mg/m²)
- •2.2. BEAM or LEAM (carmustine 300 mg/m² or lomustine 200 mg/m² with: etoposide 800 mg/m²; cytarabine 1600 mg/m²; melphalan 140 mg/m²)
- •2.3. Fludarabine-busulphan (fludarabine 120-180 mg/m²; busulphan =8 mg/kg PO or 6.4 mg/kg IV)
- •2.4. Fludarabine-treosulfan (fludarabine 150 mg/m² IV; treosulfan 30 g/m² IV)
- •3. Planned use of peripheral blood stem cells (PBSCs) for transplantation
- •4. Planned allo-SCT for one of the following haematological malignancies:
- •4.1. AML in complete remission (CR)
- •4.2. ALL in CR
- •4.3. CMML <10% blasts
- •4.4. MDS <10% blasts
- •4.5. NHL in CR/partial remission (PR)
- •4.6. HL in CR/PR
- •4.7. MM in CR/PR
- •4.8. CLL in CR/PR
- •4.9. CML in 1st or 2nd chronic phase
- •4.10. Myelofibrosis
- •5. Age 16-70 years
- •6. 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
- •Previous inclusion criteria:
- •1. Availability of suitably matched unrelated donor (9/10 or 10/10)
- •2. Planned to receive one of the following reduced-intensity conditioning (RIC) protocols:
- •2.1. Fludarabine-melphalan (fludarabine 120-180 mg/m²; melphalan =150 mg/m²)
- •2.2. BEAM or LEAM (carmustine 300 mg/m² or lomustine 200mg/m² with: etoposide 800 mg/m²; cytarabine 1600 mg/m²; melphalan 140 mg/m²)
- •2.3. Fludarabine-busulphan (fludarabine 120-180 mg/m²; Busulphan =8 mg/kg PO or 6.4 mg/kg IV)
- •3. Planned use of peripheral blood stem cells (PBSCs) for transplantation
- •4. Planned allo-SCT for one of the following haematological malignancies:
- •4.1. AML in complete remission (CR)
- •4.2. ALL in CR
- •4.3. CMML <10% blasts
- •4.4. MDS <10% blasts
- •4.5. NHL in CR/partial remission (PR)
- •4.6. HL in CR/PR
- •4.7. MM in CR/PR
- •4.8. CLL in CR/PR
- •4.9. CML in 1st or 2nd chronic phase
- •4.10. Myelofibrosis
- •5. Age 16-70 years
- •6. 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
排除标准
- •Current exclusion criteria as of 29/08/2023:
- •1. Use of any method of graft manipulation (excluding storage of future donor lymphocyte infusion)
- •2. Use of alemtuzumab or any method of T-cell depletion except those that are protocol-defined
- •3. Known hypersensitivity to study drugs or history of hypersensitivity to rabbits
- •4. Pregnant or lactating women
- •5. Adults of reproductive potential not willing to use appropriate, highly effective, contraception during the specified period
- •6. Life expectancy <8 weeks
- •7. Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection
- •8. Organ dysfunction defined as:
- •8.1. Left ventricular ejection fraction (LVEF) <45%
- •8.2. Glomerular filtration rate (GFR) <50 ml/min
- •8.3. Bilirubin >50 µmol/l
- •8.4. Aspartate transaminase (AST) or alanine transferase (ALT) >3 x upper limit of normal (ULN)
- •9. Participation in COSI or ALL-RIC trials
- •10. Contraindication to treatment with the study drugs (Thymoglobulin, cyclophosphamide, sirolimus, ciclosporin and mycophenolate mofetil) as detailed in each study drug SmPC
- •11. Patient has any other systemic dysfunction (e.g., gastrointestinal, renal, respiratory, cardiovascular) or significant disorder which, in the opinion of the investigator would jeopardise the safety of the patient by taking part in the trial
- •Previous exclusion criteria:
- •1. Use of any method of graft manipulation (excluding storage of future donor lymphocyte infusion)
- •2. Use of alemtuzumab or any method of T-cell depletion except those that are protocol-defined
- •3. Known hypersensitivity to study drugs or history of hypersensitivity to rabbits
- •4. Pregnant or lactating women
- •5. Adults of reproductive potential not willing to use appropriate, highly effective, contraception during the specified period
- •6. Life expectancy <8 weeks
- •7. Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection
- •8. Organ dysfunction defined as:
- •8.1. Left ventricular ejection fraction (LVEF) <45%
- •8.2. Glomerular filtration rate (GFR) <50 ml/min
- •8.3. Bilirubin >50 µmol/l
- •8.4. Aspartate transaminase (AST) or alanine transferase (ALT) >3 x upper limit of normal (ULN)
- •9. Participation in COSI or ALL-RIC trials
研究者
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