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Clinical Trial Summary

In a proportion of patients with AL amyloidosis there is no improvement of cardiac function despite hematologic response to treatment. The aim of the study is to assess whether treatment with EGCG increases the rate of cardiac response in patients with AL amyloidosis who completed chemotherapy.


Clinical Trial Description

This will be a phase II open-label randomized trial. Patients with AL amyloidosis and cardiac involvement who have achieved at least partial hematologic response after chemotherapy will be randomized to receive standard supportive therapy (SST) or SST plus Epigallocatechin gallate (EGCG). After giving written informed consent, the patients will be evaluated for eligibility. Briefly, the subjects with a biopsy-proven diagnosis of AL amyloidosis who achieved at least partial response after chemotherapy, who are not planned to receive further chemotherapy and who have significant cardiac dysfunction will be considered eligible. The patients will be stratified according to the quality of hematologic response and to the severity of cardiac involvement. Following stratification, the patients will be randomized to receive SST or SST plus EGCG. The study comprises 3 periods: screening (including stratification and randomization), treatment (with evaluations of response every 2 months) followed by the end-of-treatment evaluation and follow-up. Therapy will continue for up to 1 year. After treatment patients will be followed for 3 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01511263
Study type Interventional
Source IRCCS Policlinico S. Matteo
Contact
Status Terminated
Phase Phase 2
Start date January 2012
Completion date July 2016

See also
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Completed NCT03923920 - Screening for Systemic Amyloidosis Via the Ligamentum Flavum
Withdrawn NCT01531751 - High Cut-off Hemodialysis in Patients With Advanced Cardiac AL Amyloidosis and End Stage Renal Disease Phase 2
Completed NCT01510613 - Pomalidomide and Dexamethasone (PDex) in AL Amyloidosis Phase 2