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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02015312
First Posted: December 19, 2013
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Florian Michel, University Hospital Heidelberg
  Purpose
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.

Condition Intervention Phase
Light Chain (AL) Amyloidosis Cardiac Involvement Drug: Epigallocatechin-3-gallate (EGCG) Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Trial for the Treatment of Cardiac AMyloid Light-chain Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)

Resource links provided by NLM:


Further study details as provided by Florian Michel, University Hospital Heidelberg:

Primary Outcome Measures:
  • compare the 12 month change in left ventricular mass [ Time Frame: 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:
  • Change in Quality of Life [ Time Frame: baseline, 12 month ]
    Quality of Life, evaluated with EORTC-QLQ-C30

  • safety of EGCG [ Time Frame: 12 month ]
    Number of adverse events according to CTC criteria (Version 4.0)

  • change in cardiac biomarkers [ Time Frame: Baseline, 12 Month ]
    cardiac troponin T (hsTNT), NTproBNP

  • improvement of hematological remission [ Time Frame: Baseline, 12 Month ]
    Hematological Response according to Palladini et al 2012

  • Organ response in affected organs other than heart [ Time Frame: Baseline, 12 Month ]
    Organ response according to Gertz et al 2005

  • Overall Survival [ Time Frame: 12 Month ]

Enrollment: 38
Study Start Date: April 2013
Study Completion Date: October 11, 2017
Primary Completion Date: October 11, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: Epigallocatechin-3-gallate (EGCG)

Pharmaceutical formulation: 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

Other Names:
  • Epigallocatechin gallate
  • EGCG
  • Epigallocatechin 3-gallate
  • Tea catechin
  • Epigallocatechin-3-gallate
Placebo Comparator: 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

Drug: Placebo

Pharmaceutical formulation: 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

Other Name: Mannitol 99.5% + highly dispersed silicon dioxide 0.5%

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02015312


Locations
Germany
University Hospital of Heidelberg; Medical Department V
Heidelberg, Baden-Württemberg, Germany, 69120
Sponsors and Collaborators
Florian Michel
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Stefan Schönland, MD University Hospital of Heidelberg
  More Information

Responsible Party: Florian Michel, Study Coordinator, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT02015312     History of Changes
Other Study ID Numbers: TAME-AL
2012-004520-38 ( EudraCT Number )
First Submitted: November 18, 2013
First Posted: December 19, 2013
Last Update Posted: October 17, 2017
Last Verified: October 2017

Keywords provided by Florian Michel, University Hospital Heidelberg:
Amyloidosis

Additional relevant MeSH terms:
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents