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

Florian Michel

Status and phase: Completed; Phase 2

Conditions: Light Chain (AL) Amyloidosis; Cardiac Involvement

Treatments: Drug: Epigallocatechin-3-gallate (EGCG); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02015312

2012-004520-38 (EudraCT Number)

TAME-AL

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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38 participants in 2 patient groups, including a placebo group

Epigallocatechin-3-gallate (EGCG)

Experimental group

Description:

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

Treatment:

Drug: Epigallocatechin-3-gallate (EGCG)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo