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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University Hospital Heidelberg
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Florian Michel, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT02015312
First received: November 18, 2013
Last updated: December 12, 2013
Last verified: December 2013
  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)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 University Hospital Heidelberg:

Primary Outcome Measures:
  • compare the 12 month change in left ventricular mass [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Quality of Life, evaluated with EORTC-QLQ-C30

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

  • change in cardiac biomarkers [ Time Frame: Baseline, 12 Month ] [ Designated as safety issue: No ]
    cardiac troponin T (hsTNT), NTproBNP

  • improvement of hematological remission [ Time Frame: Baseline, 12 Month ] [ Designated as safety issue: No ]
    Hematological Response according to Palladini et al 2012

  • Organ response in affected organs other than heart [ Time Frame: Baseline, 12 Month ] [ Designated as safety issue: No ]
    Organ response according to Gertz et al 2005

  • Overall Survival [ Time Frame: 12 Month ] [ Designated as safety issue: No ]

Estimated Enrollment: 38
Study Start Date: April 2013
Estimated Primary Completion Date: August 2015 (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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02015312

Contacts
Contact: Stefan Schönland, MD 0049 6221 56 8009 stefan.schoenland@med.uni-heidelberg.de
Contact: Ute Hegenbart, MD 0049 6221 56 8009 ute.hegenbart@med.uni-heidelberg.de

Locations
Germany
University Hospital of Heidelberg; Medical Department V Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Stefan Schönland, MD    +49 6221 56 8009    stefan.schoenland@med.uni-heidelberg.de   
Contact: Ute Hegenbart, MD    +49 6221 56 8009    ute.hegenbart@med.uni-heidelberg.de   
Principal Investigator: Stefan Schönland, MD         
Sub-Investigator: Ute Hegenbart, MD         
Sponsors and Collaborators
Florian Michel
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Stefan Schönland, MD University Hospital of Heidelberg
  More Information

No publications provided

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
Study First Received: November 18, 2013
Last Updated: December 12, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Heidelberg:
Amyloidosis

Additional relevant MeSH terms:
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Neuroprotective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 27, 2014