EUCTR2009-016898-14-FR进行中（未招募）不适用
Phase II study of first line treatment of chronic graft versus host disease with the association of ciclosporine, corticosteroids and Rituximab - R-GVHD
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •- Adult patients (=18 years) who have received a first allogeneic stem cell transplantation for a hematological disease
- •- Confirmed diagnosis of first episode of chronic GVHD requiring systemic immunosuppres-sive therapy. Chronic GVHD diagnosis is defined according to the NIH Working Group Con-sensus. Chronic GVHD diagnosis will be based on the evaluation of the severity of the differ-ent clinical manifestations including :
- •a/ Occular, oral and mucosal symptoms,
- •b/ Performance status evaluation,
- •c/ Pulmonary function evaluation,
- •d/ Cutaneaous evaluation measured by the percentage of extension of manifestations of liche-noid or sclerodermatous aspects, eventually confirmed with a biopsy whenever possible,
- •e/ Evaluation of the musculo-squelettal manifestations, especially the amplitude of the relevant articulations,
- •f/ Evaluation of liver involvement (Total bilirubin, Transaminases, Phosphatase alcalines and Gamma GT).
- •- Any source of hematopoietic stem cells is authorized.
- •- Any category of conditioning regimen prior to allo-SCT is authorized.
- •- Any type of stem cell donors is authorized.
- •- Signed informed consent.
- •- Any prior GVHD prophylaxis previously used is accepted.
- •- Absence of contra-indications to the use of Rituximab.
- •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
- •- Patient developing acute GVHD (whether early or late onset” form)
- •- A limited” form of chronic GVHD not requiring systemic immunosuppressive therapy
- •- Treatment with prednisone (or equivalent) at doses higher than 1 mg/kg/day at the time of enrollment. Persistent prednisone treatment of acute GVHD that is less than 1mg/kg is allowed (i.e. Patient was treated for acute GVHD with prednisone, and developed chronic GVHD before completing taper).
- •- GVHD occurring following donor lymphocytes infusion (DLI)
- •- Not the first episode of chronic GVHD needing systemic immunosuppressive therapy
- •- Neutropenia <500/µL
- •- Second allogeneic stem cell transplant
- •- Uncontrolled systemic infection which in the opinion of the investigator is associated with an increased risk of the patient’s death within 1 month after the start of therapy
- •- Severe neurological or psychiatric disorders
研究者
相似试验
进行中（未招募）
1 期
Phase II study of first line treatment of Chronic Graft versus Host Disease with Arsenic TrioxideFirst line treatment of Chronic Graft versus Host Disease in patients having received a first allogeneic stem cell transplantation for a hematological diseaseEUCTR2016-002358-18-FRMedsenic24
招募中
不适用
Phase I/II study of Second-lIne therapy of preoperative cheMoradiothERApy with gemcitabine and nab-paclitaxel for locally advanced pancreatic canceR (SIMERAR trial)Patients with locally advanced pancreatic cancer (BR-A or UR-LA) scheduled for pancreatic resectionJPRN-UMIN000046618Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama45
招募中
2 期
Phase-2 clinical trial on the treatment of chronic dysphagia in head and neck cancer patients with dedicated strengthening exercises using the Swallow Exercise AidDysphagiaswallowing impairment10027656NL-OMON42230Antoni van Leeuwenhoek Ziekenhuis20
进行中（未招募）
不适用
A phase II study for the treatment of patients with splenic marginal lymphoma with the combination of Cyclophosfamide, Vincristine, Liposomal Doxorubicin, Predinisone and RituximabTreatment of patients with newly diagnosed splenic marginal non Hodgkin lymphomaMedDRA version: 9.1Level: LLTClassification code 10062113Term: Splenic marginal zone lymphomaEUCTR2005-000693-45-ITG.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI
已完成
2 期
Phase II trial of early secondary treatment with nibolumab for non-small cell lung cancernon-small cell lung cancerJPRN-UMIN000030457Fujita Health University School30