A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)

Phase 2

Completed

• Conditions: Cardiac Involvement; Light Chain (AL) Amyloidosis
• Interventions: Drug: Epigallocatechin-3-gallate (EGCG); Drug: Placebo

• Registration Number: NCT02015312
• Lead Sponsor: Florian Michel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-12-12
• Study First Posted: 2013-12-19
• Status Verified: 2017-10
• Primary Completion: 2017-10-11
• Study Completion: 2017-10-11
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epigallocatechin-3-gallate (EGCG)	Epigallocatechin-3-gallate (EGCG)	EGCG 400 mg/d p.o. for 3 months; 800 mg/d p.o. for 3 months, 1200 mg/d p.o. for 6 months
Placebo	Placebo	capsules Dose: 400 mg/d for 3 months; 800 mg/d for 3 months, 1200 mg/d for 6 months Route of administration: p.o. Treatment duration: 12 months

Primary Outcome Measures

Name	Time	Method
compare the 12 month change in left ventricular mass	12 month	The primary analysis to compare the 12 month change in left ventricular mass between the two treatment arms will be performed by a one-sided two-sample t test at a significance level of 0.025.

Secondary Outcome Measures

Name	Time	Method
Organ response in affected organs other than heart	Baseline, 12 Month	Organ response according to Gertz et al 2005
safety of EGCG	12 month	Number of adverse events according to CTC criteria (Version 4.0)
Overall Survival	12 Month
Change in Quality of Life	baseline, 12 month	Quality of Life, evaluated with EORTC-QLQ-C30
change in cardiac biomarkers	Baseline, 12 Month	cardiac troponin T (hsTNT), NTproBNP
improvement of hematological remission	Baseline, 12 Month	Hematological Response according to Palladini et al 2012

Trial Locations

Locations (1)

University Hospital of Heidelberg; Medical Department V; 🇩🇪 Heidelberg, Baden-Württemberg, Germany