A Phase 3, Randomized, Open-Label, Multicenter Study, to Compare T-Guard to Ruxolitinib for the Treatment of Patients with Grade III or IV Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)

Xenikos B.V.0 个研究点目标入组 246 人开始时间: 2021年10月19日最近更新: 2022年3月2日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 246

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. Patients must be at least 18.0 years of age at the time of consent.
•2. Patient has undergone first allo-HSCT from any donor source or graft source.
•3. Patients diagnosed with Grade III or IV SR-aGVHD after allo-HSCT. SR includes aGVHD initially treated at a lower steroid dose, but must meet one of the following criteria:
•progressed or new organ involvement after 3 days of treatment with methylprednisolone (or equivalent) of greater than or equal to 2 mg/kg/day,
•no improvement after 7 days of primary treatment with methylprednisolone (or equivalent) of greater than or equal to 2mg/kg/day
•patients with visceral (GI and/or liver) plus skin aGVHD at methylprednisolone (or equivalent) initiation with improvement in skin GVHD without any improvement in visceral GVHD after 7 days of primary treatment with methylprednisolone (or equivalent) of greater than or equal to 2mg/kg/day
•Patients who have skin GVHD alone and develop visceral aGVHD during treatment with methylprednisolone (or equivalent) of greater than or equal to 1mg/kg/day and do not improve after 3 days of greater than or equal to 2mg/kg/day
•4. Patients must have evidence of myeloid engraftment (e.g., absolute neutrophil count greater than or equal to 0.5 × 109/L for 3 consecutive days if ablative therapy was previously used). Use of growth factor supplementation is allowed.
•5. Patients or an impartial witness (in case the patient is capable to provide verbal consent but not capable to sign the informed consent) should have given written informed consent.
•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 225
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 37

排除标准

•1. Patients who have a creatinine greater than or equal to 2mg/dL or estimated creatinine clearance less than 40 mL/min or those requiring hemodialysis.
•2. Patients who have been diagnosed with active Thrombotic Microangiopathy (TMA), defined as meeting all the following criteria:
•greater than 4% schistocytes in blood (or equivalent if semiquantitative scale is used e.g., 3+ or 4+ schistocytes on peripheral blood smear),
•de novo, prolonged or progressive thrombocytopenia (platelet count less than 50 x 109/L or 50% or greater reduction from previous counts),
•sudden and persistent increase in lactate dehydrogenase concentration greater than 2x ULN,
•decrease in hemoglobin concentration or increased transfusion requirement attributed to Coombs-negative hemolysis, AND
•decrease in serum haptoglobin
•3. Patients who have previously received treatment with eculizumab.
•4. Patients who have previously received checkpoint inhibitors (either before or after allo-HCT).
•5. Patients who have been diagnosed with overlap syndrome, that is, with any concurrent features of cGVHD.
•6. Patients requiring mechanical ventilation or vasopressor support.
•7. Patients who have received any systemic treatment, besides steroids, as upfront treatment of aGVHD or as treatment for SR-aGVHD. Reinstitution of previously used GVHD prophylaxis agents (e.g., tacrolimus, cyclosporin, MTX, MMF) or substitutes in cases with previously documented intolerance will be permitted. Previous treatment with a JAK inhibitor as part of GVHD prophylaxis or treatment is not allowed.
•8. Patients who have severe hypoalbuminemia, with an albumin of less than or equal to 1 g/dl.
•9. Patients who have a creatine kinase (CK) level of greater than 5 times the upper limit of normal.
•10. Patients with uncontrolled infections. Infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, no signs of progression are present. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. Progression of infection is defined as:
•hemodynamic instability attributable to sepsis OR
•new symptoms attributable to infection OR
•worsening physical signs attributable to infection OR
•worsening radiographic findings attributable to infection
•11. Patients with evidence of relapsed, progressing, or persistent malignancy, or who have been treated for relapse after transplant, or who may require rapid immune suppression withdrawal as pre-emergent treatment of early malignancy relapse.
•12. Patients with evidence of minimal residual disease requiring withdrawal of systemic immune suppression.
•13. Patients with unresolved serious toxicity or complications (other than acute GVHD) due to previous transplant.
•14. History of sinusoidal obstruction syndrome (SOS)/veno-occlusive disease (VOD).
•15. Patients with known hypersensitivity to any of the components murine monoclonal antibodies (mAb) or recombinant Ricin Toxin A-chain (RTA).
•16. Patients who have had treatment with any other investigational agent, device, or procedure within 21 days (or 5 half-lives, whichever is greater) prior to enrollment.
•17. Patients who have received more than one allo-HSCT.
•18. Patients with known human immunodeficiency virus infection.
•19. Patients who have a BMI greater than or equal to 35 kg/m2.
•20. Patients who are taking sirolimus must have it discontinued prior to starting study treatment.
•21. Female patients who are pregnant, breast f

研究者

发起方

Xenikos B.V.

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已完成

3 期

A Phase 3, Randomized, Open-Label, Multicenter Study, to Compare T-Guard to Ruxolitinib for the Treatment of Patients with Grade III or IV Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)

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