ISRCTN13400668已完成1 期
A Phase I/IIa Study of Targeted Radiotherapy alone for Stem Cell Transplant Conditioning in Systemic AL Amyloidosis
niversity Hospital Southampton NHS Foundation Trust0 个研究点目标入组 10 人开始时间: 2016年11月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged =18 years
- •2. Diagnosis of systemic AL-amyloidosis, either as a new diagnosis or recurrent disease
- •3. Measurable clonal plasma cell dyscrasia
- •4. Amyloid related organ dysfunction or organ syndrome
- •5. Estimated life expectancy of at least 6 months (as defined at trial entry)
- •6. Sufficient stem cells for two transplant procedures
- •7. Bone Marrow (BM) cellularity >20%
- •8. Eligible for ASCT in AL amyloidosis defined as fulfilling all of the following criteria:
- •8.1. ECOG Performance Status of 0 or 1
- •8.2. Cardiac troponin-T <0.07 µg/L
- •8.3. NYHA heart failure class of <3
- •8.4. No more than 3 organs involved by amyloidosis by consensus guidelines
- •8.5. Creatinine clearance or isotope GFR =30ml/min
- •8.6. Bilirubin =1.5 times and alkaline phosphatase =3 x upper limit of normal
- •8.7. AST or ALT <2.5 x upper limit of normal range
- •8.8. Mean left ventricular wall thicknesses of <16mm by echocardiography
- •8.9. Absence of clinically important amyloid related autonomic neuropathy
- •8.10. Absence of clinically important amyloid related gastro intestinal haemorrhage
- •9. Capable of providing written, informed consent
- •10. Women of child bearing potential should use adequate forms of contraception
- •10.1. Intrauterine Device (IUD)
- •10.2. Hormonal based contraception (pill, contraceptive injection etc.)
- •10.3. Double Barrier contraception (condom and occlusive cap e.g. diaphragm or cervical cap with spermicide)
- •10.4. True abstinence (this is defined as refraining from heterosexual intercourse after receiving [111In] at the Dosimetry and Imaging visit through to final study visit
排除标准
- •1. Overt symptomatic multiple myeloma
- •2. Amyloidosis of unknown or non AL type
- •3. 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)
- •4. Trivial or incidental AL amyloid deposits in the absence of a significant amyloid related organ syndrome (e.g., isolated carpal tunnel syndrome)
- •5. NYHA Class III or IV heart failure
- •6. Liver involvement by amyloid causing bilirubin >1.5 times upper limit of normal
- •7. Concurrent active malignancies, except surgically removed basal cell carcinoma of the skin or other in situ carcinomas
- •8. Pregnant, lactating or unwilling to use adequate contraception
- •9. Intolerance / sensitivity to any of the study drugs
- •10. Known positive Human anti-murine antibodies (HAMA)
- •11. Unable to provide written informed consent
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