Treatment of severe steroid-refractory acute GvHD with mesenchymal stromal cells. A phase III randomized double-blind multi-center HOVON study. - HOVON 113 MSC

HOVO0 个研究点目标入组 75 人开始时间: 待定最近更新: 2024年4月29日

适应症

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);
•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).

•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;
•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 higly 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.

发起方

HOVO