EUCTR2015-002231-18-GB进行中（未招募）不适用
A Phase I/IIa Study of Targeted Radiotherapy alone for Stem Cell Transplant Conditioning in Systemic AL Amyloidosis - Targeted Radiotherapy for AL-Amyloidosis –‘TRALA’
niversity Southampton Hospital NHS Foundation Trust0 个研究点目标入组 18 人开始时间: 2015年9月23日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
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
- 性别
- All
入选标准
- •The main inclusion criteria is patients with systemic AL-amyloidosis with an indication for treatment who satisfy all standard transplant inclusion criteria (good organ function, no significant heart involvement, good performance status).
- •Aged =18 years.
- •Have a diagnosis of systemic AL-amyloidosis, either as a new diagnosis or recurrent disease.
- •Measurable clonal plasma cell dyscrasia.
- •Amyloid related organ dysfunction or organ syndrome.
- •Estimated life expectancy of at least 6 months (as defined at trial entry).
- •Sufficient stem cells for two transplant procedures .
- •Bone Marrow (BM) cellularity >20%.
- •Eligible for ASCT in AL amyloidosis defined as fulfilling all of the following criteria :
- •oECOG Performance Status of 0 or 1
- •oCardiac troponin-T <0.07 µg/L
- •oNYHA heart failure class of <3
- •oNo more than 3 organs involved by amyloidosis by consensus guidelines.
- •oCreatinine clearance or isotope GFR =30ml/min.
- •oBilirubin =1.5 times and alkaline phosphatase =3 x upper limit of normal.
- •oAST or ALT <2.5 x upper limit of normal range.
- •oMean left ventricular wall thicknesses of <16mm by echocardiography.
- •oAbsence of clinically important amyloid related autonomic neuropathy .
- •oAbsence of clinically important amyloid related gastro intestinal haemorrhage.
- •Capable of providing written, informed consent.
- •Women of child bearing potential should use adequate forms of contraception.
- •oIntrauterine Device (IUD)
- •oHormonal based contraception (pill, contraceptive injection etc.)
- •oDouble Barrier contraception (condom and occlusive cap e.g. diaphragm or cervical cap with spermicide)
- •oTrue abstinence
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •Patients with poor performance, advanced organ involvement or significant cardiac involvement will be excluded from the study.
- •Patients with the following characteristics are ineligible for this study:
- •Overt symptomatic multiple myeloma.
- •Amyloidosis of unknown or non AL type.
- •Localised AL-amyloidosis (in which amyloid deposits are limited to a typical single organ, for example the bladder or larynx, in association with a clonal proliferative disorder within that organ).
- •Trivial or incidental AL amyloid deposits in the absence of a significant amyloid related organ syndrome (e.g., isolated carpal tunnel syndrome).
- •NYHA Class III or IV heart failure (appendix 1).
- •Liver involvement by amyloid causing bilirubin >1.5 times upper limit of normal.
- •Concurrent active malignancies, except surgically removed basal cell carcinoma of the skin or other in situ carcinomas.
- •Pregnant, lactating or unwilling to use adequate contraception as listed above
- •Intolerance / sensitivity to any of the study drugs.
- •Known positive Human anti-murine antibodies (HAMA).
- •Unable to provide written informed consent
- •Involved in another IMP trial
研究者
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