NL-OMON50082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) - Phase 3 study of T-Guard versus ruxolitinib in SR-aGVHD
Xenikos B.V.0 个研究点目标入组 15 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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
- 年龄范围
- 18 至 99（—）
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
- •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.
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
- •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
- •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)
- 另有 4 项未显示
研究者
相似试验
进行中（未招募）
1 期
A Phase 3, Randomized, Open-Label, Multicenter Study Comparing the Efficacy and Safety of the medications BGB-3111 and Ibrutinib in Subjects with Waldenström’s Macroglobulinemia (WM)Subjects with Waldenström’s Macroglobulinemia (WM) who require therapy according to the consensus panel criteria from the 7th International Workshop on Waldenström’s MacroglobulinemiaMedDRA version: 20.0Level: PTClassification code 10047801Term: Waldenstrom's macroglobulinaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-002980-33-BEBeiGene USA, Inc.210
进行中（未招募）
1 期
A Phase 3, Randomized, Open-Label, Multicenter Study Comparing the Efficacy and Safety of the medications BGB-3111 and Ibrutinib in Subjects with Waldenström’s Macroglobulinemia (WM)Subjects with Waldenström’s Macroglobulinemia (WM) who require therapy according to the consensus panel criteria from the 7th International Workshop on Waldenström’s MacroglobulinemiaMedDRA version: 20.0Level: PTClassification code 10047801Term: Waldenstrom's macroglobulinaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-002980-33-CZBeiGene USA, Inc.210
进行中（未招募）
1 期
Research study to evaluate the experimental drug ferumoxytol, to see how well it works for children with chronic kidney disease (CKD) and iron deficiency anemia (IDA) or who are at risk of developing IDA, and to see how safe it is compared to another marketed iron product – iron sucrose.EUCTR2017-004026-15-HUAMAG Pharmaceuticals, Inc.129
进行中（未招募）
1 期
Research study to evaluate the experimental drug ferumoxytol, to see how well it works for children with iron deficiency anemia (IDA) or who are at risk of developing IDA, and to see how safe it is compared to another marketed iron product – iron sucrose.Iron Deficiency Anemia (IDA) in Pediatric SubjectsMedDRA version: 20.0 Level: LLT Classification code 10022974 Term: Iron deficiency anemia System Organ Class: 100000004851EUCTR2018-004304-19-LTAMAG Pharmaceuticals, Inc.75
进行中（未招募）
1 期
A study to compare the experimental medicine T-Guard to Ruxolitinib for treating acute Graft-versus-Host Disease that does not sufficiently improve with the standard steroid treatmentPatients with Grade III or IV Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)MedDRA version: 20.0Level: LLTClassification code 10068908Term: AGVHDSystem Organ Class: 100000004870EUCTR2021-000343-53-ESXenikos B.V.246