NCT01509560已完成2 期
PhaseII,Open-label,Pilot Study Evaluating the Safety+Efficacy of Certican ® in the Prevention of Chronic Graft-versus-host Disease+Late Pulmonary Complications After Allogeneic Hematopoietic Cell Transplantation Blood
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2011年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Frequency of early withdrawal of treatment within the first 6 weeks on Everolimus
研究概览
简要总结
In this prospective study is to examine whether the use of everolimus in patients after allogeneic SCT as part of GVHD prophylaxis for a further review in clinical studies is appropriate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients after allogeneic stem cell transplantation aged ≥ 18 years
- •Prophylaxes of GvHD with calcineurin inhibitors (Ciclosporine A, Tacrolimus) and MTX or MMF (previous therapy of acute GvHD with additional prednisone is permitted)
- •Increased risk of chronic GvHD, defined by
- •Male with female donor
- •HLA mismatch class I- or II towards GvHD
- •Persistant active acute GvHD on day +50 after stem cell transplantation despite of high-dose steroids and cyclosporine
- •Reduction of baseline FEV1 or DLCO (examined 0 - 50 days before transplantation) of ≥ 25%
- •New occurrence of acute GvHD between day +50 and +100 after stem cell transplantation
- •Informed concent
排除标准
- •Use (prophylactic or therapeutic) of mTor inhibitors after SCT
- •Overlap of acute and chronic GvHD
- •Total cholesterol ≥ 3-fold of upper limit (UL) or triglycerides ≥ 3-fold UL
- •GOT, GPT, Bilirubin ≥ 3-fold UL (if not related to GvHD)
- •Creatinine ≥ 3-fold UL
- •Confirmed active hepatitis B or C
- •All circumstances where impaired wound healing might be a risk factor, esp. surgical interventions in the last weeks, ulcers of skin or mucosa
- •Known intolerance to Everolimus, Sirolimus or other compoments of Certican®
- •Lactose intolerance
- •Pregnancy or lactation
- •Women in reproductive age, except of women with the following criteria:
- •Postmenopausal (12 month natural amenorrhea)
- •Postoperativ (≥ 6 months after bilateral ovariectomy with / without hysterectomy)
- •During therapy and at least 6 months after the last application of Everolimus: regular and correct high-effective contraception (Pearl-Index < 1; e. g. oral contraception, intrauterine device, implantate, contraceptive patch, combination of barrier methods (condom and cervical cap/diaphragm), abstinence
- •Men, not using one of the following methods of contraception during therapy and at least 6 month after the last application of Everolimus:
- •Sexual abstinence
- •Vasectomy
- •Impairments or diseases reducing the ability of informed consent
- •Participation of another study (e.g. for prophylactic immunsuppression in the stem cell transplantation procedure) within the last 60 day before recruitment
研究组 & 干预措施
Everolimus
Experimental
All patients will be given everolimus and the magnitude of the side effects will be measured
干预措施: Everolimus (Drug)
结局指标
主要结局
Frequency of early withdrawal of treatment within the first 6 weeks on Everolimus
时间窗: 16 months
Primary endpoint Frequency of early withdrawal of treatment within the first 6 weeks on Everolimus Reasons for withdrawal of Everolimus treatment: * Unacceptabel toxicity * Therapy failure: * Recurrence of moderate or severe chronic GvHD (according to NIH criteria), clearly differentiated from acute forms of GvHD * Reduction of LFS of more than 25% compared to the last value within 14 days before Everolimus treatment * Therapy with immunosuppressive drugs in addition to Everolimus
次要结局
- Adverse drug reactions on Everolimus(16 months)
研究者
研究点 (1)
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