EUCTR2012-004915-30-NL进行中（未招募）1 期
Treatment of severe steroid-refractory acute GvHD with mesenchymal stromal cells.A phase III, randomized double-blind multi-center HOVON study. - HOVON 113 MSC
HOVON Foundation0 个研究点目标入组 150 人开始时间: 2013年1月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- •Grade II-IV acute GvHD with gut and/or liver involvement, confirmed by histology of involved tissues (in case of gut and liver involvement histology of either one of these tissues is considered sufficient); N.B. if histological confirmation at randomization is lacking or inconclusive but the patient is otherwise eligible and acute GvHd is considered the most likely cause of the symptoms, the patient may be included but histology of involved tissue (if lacking) should still be obtained as soon as deemed feasible and/or safe
- •Steroid-refractory defined as progressive disease, mixed response, or grade IV disease after at least 5 days, or stable grade II-III disease after at least 7 days of consecutive systemic treatment with steroids at a dose of = 2 mg/kg prednisolone or steroid equivalent and a calcineurin-inhibitor at therapeutic trough levels
- •Lansky / Karnofsky score of =20;
- •Signed informed consent by the patient and/or parent(s) or legal guardian(s).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 125
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Use of intravenous prophylactic MMF = 6 days prior to development of acute GvHD ;
- •Systemic treatment for acute GvHD other than steroids and a calcineurin inhibitor (budesonide is considered a local treatment);
- •Consecutive treatment with steroids = 2 mg/kg prednisolone or steroid equivalent > 10 days directly prior to inclusion;
- •Previous treatment with advanced therapy medicinal products (ATMP) potentially interfering with the endpoints of this study;
- •N.B. if there is doubt regarding potential interference, the principal investigator should always be contacted prior to registration*.
- •Known progressive or relapsing malignant disease in case of NHL, HL, CLL, MM, and = 5% blasts in the bone marrow in case of AML, ALL, CML;
- •Requiring ventilator or vasopressor support;
- •Poor performance not expected to survive 14 days;
- •Known uncontrolled hypersensitivity to DMSO;
- •History of any other malignancy, unless diagnosed and treated > 5 years ago with curative intent and without recurrence or nonmelanoma skin cancer and/or carcinoma in situ of any type following complete resection.
- •Known pregnancy, a positive highly sensitive pregnancy test at screening, or lactation for female patients; unwillingness to practice highly effective means of contraception for both female and male patients of reproductive potential, as described in paragraph 9.4;
- •Any psychological, familial, sociological and /or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
研究者
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