EUCTR2007-005009-24-BE进行中（未招募）不适用
An international randomised, multicentre, parallel-group, Phase III comparative study of inolimomab against usual care in the treatment of Primary Steroid Refractory Acute Graft versus Host Disease (aGvHD) following allogeneic Stem Cell Transplantation in adult patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •1. age > or = 18 years
- •2. first allogeneic bone marrow or peripheral Stem Cell Transplantation from HLA-matched sibling donor or 10/10 HLA unrelated donor or 9/10 HLA donor for treatment of hematological malignancy or aplastic anaemia
- •3. patients can have received either a myeloablative or reduced-intensity conditioning regimen. Patients who have received a reduced-intensity conditioning regimen can be included if their first acute GvHD episode is within 6 months after the HSCT (within 100 days for the patients with standard myeloablative conditioning regimen)
- •4. patients must be in Complete Remission or in chronic Phase (concerning the CML) or at least in stable disease (concerning CLL, high and low grade NHL, HL, myeloma, myeloproliferative diseases and myelodysplasia) from the underlying hematological malignancy at the time of SCT. Patients with aplastic anaemia requiring allogeneic transplantation.
- •5. GvHD prophylaxis with: short regimens (D1, D3 and D6 or D1, D3, D6 and D11) of methotrexate and cyclosporine or tacrolimus OR MMF (D-1 to D28) and cyclosporine (or tacrolimus) OR MMF (D-1 to D90) in case of HLA unrelated donor OR cyclosporine (or tacrolimus) alone for patients receiving in-vivo T-cells depleted graft (with ATG) OR Sirolimus at the following dosage: Day -3: 1 dose of 6 mg (upload dose); Day -2: 1 dose of 2 mg; then dose adaptation to reach values between 5-15 ng/ml and this to day 100 for related donors and to day 180 for MUD transplants. After that a gradual reduction to 0.
- •6. patient with the first episode of grade II to IV aGvHD (according to modified Glucksberg scoring system) developed within 100 days after HSCT and patients who have received a reduced-intensity conditioning regimen if their first acute GvHD episode is within 6 months after the HSCT (within 100 days for the patients with standard myeloablative conditioning regimen)
- •7. patient who already received MP (2mg/kg) as treatment and must have shown a resistance as defined by one of the following items: GvHD progressing after 3 days of MP treatment OR GvHD persisting after 7 days of MP treatment OR During the decrease of corticosteroids, in case of rebound of GvHD with grade equal or greater than II and as the dose of corticosteroids is still equal or more than 1 mg/kg/D
- •8. male and female patients must observe adequate birth control measures
- •9. patients must give written informed consent before completing any study related procedure which means assessment or evaluation that would not form part of the normal medical practice care of the patient
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 63
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1. post donor lymphocyte infusion GvHD
- •2. During the decrease of corticosteroids, in case of rebound of GvHD with grade inferior to II and/or if the dose of corticosteroids is less than 1 mg/kg/D
- •3. non 9/10 or 10/10 HLA- matched donor(sibling or unrelated)
- •4. transplantation other than haematological malignancy
- •5. cord blood transfusion
- •6. patients who have received prophylactic regimens of GvHD with corticosteroids
- •7. patient on mechanical ventilatory support
- •8. progression of the malignancy at the time of inclusion
- •9. serum creatinemia >30 mg/l
- •10. patient with vasopressor treatment
- •11. uncontrolled infection(s) within 72 hours prior to study entry despite adapted treatment.Neither continuation of antibiotics for a controlled infection nor prophylactic/empiric antiobiotics warrant exclusion
- •12. pregnant or lactating females
- •13. use of any investigational drug for the treatment of acute GvHD within 14 days prior to study entry
- •14. any history of hypersensitivity/allergy to murine products and any other component of study drug
- •15. positive HIV serology
- •16. ECOG >3
- •17. ASAT or ALAT > 10xULN
- •18. Serum albumin < or = 15g/l
- •19. minor patient and those incapable of giving informed consent
研究者
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