EUCTR2015-002231-18-GB
Active, Not Recruiting
N/A
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 sites18 target enrollmentSeptember 23, 2015
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Southampton Hospital NHS Foundation Trust
- Enrollment
- 18
- Status
- Active, Not Recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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