Repurposing Metformin as a Leukemia-preventive Drug in CCUS and LR-MDS

Summary

Participation Requirements

Description

The research plan is divided into three work packages (WP): WP0, Bone Marrow Adipose Tissue (BMAT) in CCUS and LR-MDS Patients: The primary objective of WP0 is to determine if patients with CCUS or LR-MDS have increased BMAT compared to age-matched healthy controls. To investigate this, we will incl...

The research plan is divided into three work packages (WP): WP0, Bone Marrow Adipose Tissue (BMAT) in CCUS and LR-MDS Patients: The primary objective of WP0 is to determine if patients with CCUS or LR-MDS have increased BMAT compared to age-matched healthy controls. To investigate this, we will include 12 elderly (?60 years) healthy controls who will have their BMAT measured by magnetic resonance spectroscopy (MRS). These will be compared to the BMAT measurements from baseline of patients described in WP1. WP1, The efficacy of metformin in CCUS and LR-MDS: In WP1, 24 patients with either CCUS or MDS will receive metformin 2000 mg/daily for 12 months with a slow-up-titration of the dose 14 days prior to full-dose treatment. Outcomes of WP1 are listed in the outcome section on this site. WP2, The efficacy of metformin compared to placebo and vitamin C: The primary objective of WP2 is to compare the effect of metformin in CCUS and LR-MDS to the effect of placebo or vitamin C treatment. To investigate this, we will include data and samples from 48 historical controls from our EVI-2 study (NCT03999723. Half of the controls received placebo for 12 months and the other half received vitamin C for 12 months.

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