EUCTR2016-003947-12-DE进行中（未招募）1 期
Treatment of steroid-resistant chronic graft-versus-host-disease with donor-derived regulatory T cells - Treg Therapy
Freistaat Bayern represented by University of Regensburg represented by Kaufmännischer Direktor0 个研究点目标入组 27 人开始时间: 2017年2月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 27
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
入选标准
- •The following criteria on screening examination have to be fulfilled:
- •Steroid-refractory moderate to severe cGVHD despite use of two or more agents (failure of 2nd line treatment). Steroid-refractory cGVHD is defined as having persistent signs and symptoms of cGVHD (Appendix D) despite the use of prednisone at = 0.25 mg/kg/day (or 0.5 mg/kg every other day) for at least 4 weeks (or equivalent dosing of other glucocorticoids) without complete resolution of signs and symptoms and continuing moderate to severe cGVHD.
- •Steroid-dependent cGVHD as indicated if >0.25 mg/kg/d prednisone are needed to prevent cGVHD recurrence or progression on 2nd line treatment or subsequent treatment lines as illustrated by two failed attempts to taper with a more than 8 wks interval
- •No dose-escalation of glucocorticoids beyond the maximum dose of the prior cGVHD treatment line within 4 wks of enrolment
- •No addition of other immunosuppressive medications (e.g., calci-neurin-inhibitors, sirolimus, mycophenolate-mofetil) for 4 weeks prior to enrolment. The dose of immunosuppressive medicines may be adjusted based on the therapeutic range of the drug
- •ECOG performance status 0-2 (Appendix X, section X)
- •Participants must have adequate organ function as defined below:
- •Hepatic: Adequate hepatic function (total bilirubin <2.0 mg/dl-exception permitted in participants with Gilbert’s Syndrome; AST (SGOT)/ALT (SGPT) =2x ULN), unless hepatic dysfunction is a manifestation of proven or presumed cGVHD. Abnormal LFTs in the context of active cGVHD involving other organ systems is permitted if the treating physician documents the abnormal LFTs as being consistent with hepatic cGVHD.
- •Pulmonary: FEV1 = 50% of predicted, unless pulmonary dysfunction is deemed to be due to chronic GVHD.
- •Age 18 -75 y
- •Written informed consent of patient
- •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 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 27
排除标准
- •Age <18 y and >75 y
- •No previous steroid therapy
- •Severe psychiatric disorders
- •Presumed life expectancy < 4 wks
- •Lack of informed consent from patient
- •Donors from outside EU (NMDP, Canadian donor registrar)
- •Participation in another interventional clinical trial according to the AMG (Arzneimittel¬gesetz) within 30 days prior to inclusion
- •T cell-depleting antibody therapy within the last 30d before enrolment
- •Pregnant or nursing woman. Sexually active women with childbearing potential or sexually active male patients unwilling to use an effective form of contraception during participation in the study from time of inclusion until 2 months after Treg therapy
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