Epigenetics, Vitamin C, and Abnormal Blood Cell Formation - Vitamin C in Patients With Low-Risk Myeloid Malignancies

Summary

The primary purpose of this multi-centre, randomized, placebo-controlled, double-blind phase II study is to investigate if oral vitamin C may change the biology of low-risk myeloid malignancies; i.e., clonal cytopenia of undetermined significance (CCUS), low-risk myelodysplastic syndromes (MDS), and chronic myelomonocytic leukemia (CMML)-0/1 by reversing the epigenetic changes characteristic of these disease entities. The epigenetic regulator TET2 is the gene most often affected in CCUS. Preclinical studies have shown that active demethylation by the TET enzymes is dependent on vitamin C, and the investigators and collaborators have shown that plasma vitamin C levels are exceedingly low in hematological cancer patients but are easily corrected by oral vitamin C. This study is part of an array of EVITA studies aimed at clarifying whether the standard of care of patients with myeloid malignancies should be changed and oral vitamin C supplement added to the treatment recommendations.

Conditions

• Myelodysplastic Syndromes
• Chronic Myelomonocytic Leukemia-1
• Cytopenia

Interventions

DIETARY_SUPPLEMENT

Vitamin C (ascorbic acid)

Monotherapy with oral vitamin C supplementation to elevate plasma vitamin C level to the upper end of the physiological range.

OTHER

Placebo

Placebo

Sponsors & Collaborators

• Van Andel Institute - Stand Up To Cancer Epigenetics Dream Team

  collaborator UNKNOWN

• University of Southern California

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• University of Copenhagen

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Technical University of Denmark

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Kirsten Grønbæk, Professor · Rigshospitalet, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-21

Primary Completion

2023-09-27

Completion

2025-09-27

Countries

• United States
• Denmark

Study Locations