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: 2015年3月11日最近更新: 2021年8月2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 principal investigator should be contacted.*
•* Non-responsive to consecutive systemic treatment with steroids at a dose of 2 mg/kg and a calcineurin-inhibitor at therapeutic trough levels, defined as:
•- progressive disease or mixed response after 5-6 days of treatment.
•- stage 4 GvHD of gut and/or liver after 5-6 days treatment and:
•· significant deterioration of clinical parameters (gut) OR
•· increase of serum total bilirubin levels in umol/L (liver)
•(not attributable to other causes than acute GvHD)
•- progressive disease after initial partial response of maximal 1 grade after 5-7 days of treatment
•- stable disease after 7 days of treatment
•See appendix A for response criteria
•* 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

•* In Spain only adult patients will be included
•* 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);
•* Pre-treatment with steroids ? 1 mg/kg for more than 3 days prior to initiation of steroids at a dose of 2 mg/kg for the treatment of acute GvHD;
•* 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 seropositivity of HIV, Hepatitis B and C, HTLV;
•* Known uncontrolled toxicity for DMSO;
•* Known anaphylactic reaction to penicillin or streptomycin;
•* Known pregnancy;
•* Any psychological, familial, sociological and /or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

发起方

HOVON Foundation