drugset / Trial / NCT03397173

TET2 Mutations in Myelodysplastic Syndromes and Acute Myeloid Leukemia With Azacitidine + Ascorbic Acid

NCT03397173

Phase 2 Completed 12 enrolled Case Comprehensive Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy of treatment with azacitidine (an FDA approved drug for the treatment of MDS) and high dose ascorbic acid in patients with TET2 mutations. This approach is intended to enhance the enzymatic activity of TET2 protein, which in term may help to improve counts and symptoms, related to Myelodysplastic Syndromes and Acute Myeloid Leukemia. This combination is specific to individuals who carry this mutation.

Timeline

Start
2018-03-16
Primary completion
2021-01-03
Completion
2021-01-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 75 mg/m2 Intravenous
Subject Vitamin C Other / unclassified 1 g Oral