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10月28日最近更新: 2017年12月11日

试验速览

暂无简介。

•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 the patient is otherwise eligible but histological confirmation at randomization is lacking, the principle investigator should be contacted.
•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

•Use of prophylactic MMF or Myfortic = 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 the patient has previously been treated with ATMP , the principal investigator should always be contacted prior to registration*.
•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 pregnancy test at screening, or lactation for female patients; unwillingness to practice effective means of contraception for both female and male patients of reproductive potential
•Any psychological, familial, sociological and /or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

发起方

HOVON Foundation