A European Open-Label, Multicentre, Phase II Study of Inolimomab in the Treatment of Primary Steroid Resistant Acute Graft versus Host Disease (aGvHD) following allogeneic Stem Cell Transplantation for Hematological Malignancies in Adult patients

OPi0 个研究点目标入组 40 人开始时间: 2006年11月2日最近更新: 2012年3月19日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: OPi
入组人数: 40

研究概览入排标准研究者记录与标识符相似试验

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 = 18 years
•2. First allogeneic bone marrow or peripheral Stem Cell Transplantation from HLA-matched sibling donor or 10/10 HLA unrelated donor for hematological malignancy
•3. Patient must have received either a myeloablative or non myeloablative regimen, but in any case with no ATG treatment.
•4. Patient must be in Complete Remission or chronic Phase (concerning the CML) or in stable disease (concerning CLL, Low grade NHL and myeloma) from the underlying Hematological malignancy at the time of the SCT
•5. GvHD prophylaxis with :·
•Short regimens (D1, D3 and D6 or D1, D3, D6 and D11) of methotrexate and cyclosporine or tacrolimus or·MMF (D1 to D28) and cyclosporine.
•6. Patient with the first episode of grade II to IV aGvHD (according to modified Glucksberg scoring system) developed within 100 days after HSCT
•7. Patients who already received MP (2mg/kg) as treatment and must have shown a resistance as defined by one of the following item:
•·GvHD progressing after 3 days;
•GvHD persisting after 7 days
•8. Patient must observe adequate birth control measures
•9.Patient must give a written informed consent (personally signed and dated) before completing any study related procedure which means assessment or evaluation that would not form part of the normal medical 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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•1. Post Donor Lymphocyte infusion GvHD
•2. Non HLA matched donor
•3. Transplantation other than hematological malignancy
•4. Cord Blood transfusion
•5. Patients who have received conditioning regimen with ATG
•6. Patient 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 creatininemia > 30 mg/l
•10. Patient with Vasopressor treatment
•11. Uncontrolled infection(s), (i.e. documented bacterial, parasitical, or fungal infection) within 72 hours prior to study entry despite adapted treatment. Neither continuation of antibiotics for a controlled infection nor prophylactic/empiric antibiotics 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 > 5xULN
•18. Serum Albumin = 15 g/l
•19. Minor patient and those incapable of giving informed consent

研究者

发起方

OPi

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