Spots Global Cancer Trial Database for Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis

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Trial Identification

Brief Title: Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis

Official Title: An Open-label Phase I/II Trial of Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Systemic Light-Chain Amyloidosis

Study ID: NCT05451771

Conditions

AL Amyloidosis

Interventions

Venetoclax Oral Tablet, 200 mg

FISH assay

Venetoclax Oral Tablet, 400 mg

Dexamethasone Oral, 10 mg

Dexamethasone Oral, 20 mg

Daratumumab Injection

Bendamustine

Pomalidomide

Ixazomib

Venetoclax MTD with Dexamethasone

Study Description

Brief Summary: The purpose of this study is assess safety, safest dose, and effectiveness of venetoclax in combination with dexamethasone in participants with t(11;14) positive relapsed (comes back) or refractory (did not get better) light chain amyloidosis.

Detailed Description: This study is a phase 1/2 study of venetoclax-dexamethasone combination therapy in relapsed/refractory t(11;14) systemic immunoglobulin light chain amyloidosis (AL) amyloidosis. The phase 1 is a dose escalation designed to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of venetoclax in combination with low-dose weekly dexamethasone. There will be four candidate-dosing cohorts of venetoclax with or without dexamethasone in the Phase I dose-escalation. Dose escalation will be guided by the Bayesian optimal interval (BOIN) design with accelerated titration up to a total sample size of 15 participants. The phase 2 portion is a randomized open-label study comparing the MTD or RP2D of venetoclax in combination with dexamethasone versus investigator's choice (daratumumab, pomalidomide, bendamustine, or ixazomib (with or without dexamethasone).