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Epigenetics, Vitamin C, and Abnormal Blood Cell Formation - Vitamin C in Patients With Low-Risk Myeloid Malignancies
Sponsor: Rigshospitalet, Denmark
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.
Official title: Epigenetics, Vitamin C, and Abnormal Hematopoiesis - Role of Vitamin C in Epigenetic Regulation in Hematopoiesis Sub-Study on CCUS, Low-Risk MDS, and CMML-0/1
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
109
Start Date
2017-11-21
Completion Date
2025-09-27
Last Updated
2024-04-17
Healthy Volunteers
No
Interventions
Vitamin C (ascorbic acid)
Monotherapy with oral vitamin C supplementation to elevate plasma vitamin C level to the upper end of the physiological range.
Placebo
Placebo
Locations (5)
Keck Hospital of University of Southern California
Los Angeles, California, United States
Rigshospitalet
Copenhagen, N/A = Not Applicable, Denmark
Aalborg University Hospital
Aalborg, Denmark
Herlev University Hospital
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark