Clinical trial NCT02015312: A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)
Official title: A Randomised Trial for the Treatment of Cardiac AMyloid Light-chain Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Light Chain (AL) Amyloidosis
Cardiac Involvement
Keywords: Amyloidosis
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2013-12-19
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and safety of epigallocatechin-3-gallate (EGCG) in patients with cardiac amyloid light-chain (AL) amyloidosis. Evaluation of clinical efficacy of EGCG intake using a pretest posttest comparison of left ventricular amyloid mass (g/m2) measured by cardiac MRI.


Eligibility criteria: Inclusion Criteria:

* Biopsy proven systemic AL amyloidosis.
* Cardiac involvement with septum thickness more than 12 mm (without other causes as published by Gertz et al., hypertension or other potential causes of left ventricular hypertrophy)
* Previously treated with chemotherapy, induced at least a very good partial remission of the underlying monoclonal plasma cell or B cell disorder.
* GPT and GOT less than 3-times ULN.
* Life expectancy more than 12 month.
* Ability of subject to understand character and individual consequences of the clinical trail.
* Written informed consent.
* For women with childbearing potential and men, adequate contraception.

Exclusion Criteria:

* Age less than 18 years.
* Concomitant multiple myeloma stage 2 and 3 (Salmon and Durie)
* Concurrent chemotherapy necessary
* Time to last chemotherapy more than 6 months.
* Chronic liver disease, Bilirubin over 1,5 mg/dl
* Not able to visit Amyloidosis Clinic in Heidelberg every 3 months.
* History of hypersensitivity to the investigational product or to any substance with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
* Participation in other clinical trials or observation period of competing trials, respectively.
* Pregnant or nursing women.

Primary outcomes:
measure: compare the 12 month change in left ventricular mass
timeFrame: 12 month
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: baseline, 12 month
measure: safety of EGCG
timeFrame: 12 month
measure: change in cardiac biomarkers
timeFrame: Baseline, 12 Month
measure: improvement of hematological remission
timeFrame: Baseline, 12 Month
measure: Organ response in affected organs other than heart
timeFrame: Baseline, 12 Month
measure: Overall Survival
timeFrame: 12 Month
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital of Heidelberg; Medical Department V
state: Baden-Württemberg
Study officials:
affiliation: University Hospital of Heidelberg
name: Stefan Schönland, MD
role: PRINCIPAL_INVESTIGATOR
References: