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Combining Active and Passive DNA Hypomethylation
Sponsor: Kirsten Grønbæk
Summary
This is a multicentre, randomized, parallel-group, placebo-controlled, double-blind phase 2 study of the efficacy and safety of oral vitamin C supplement in combination with azacitidine in patients with higher-risk MDS, CMML-2 or low-blast count AML. The primary purpose is to investigate if oral vitamin C supplementation to azacitidine, compared with azacitidine + placebo, can increase the effectiveness of epigenetic therapy in patients with higher-risk myeloid malignancies, who are not candidates for allogeneic hematopoietic stem cell transplantation.
Official title: Combining Active and Passive DNA Hypomethylation: A Randomized, Placebo-Controlled Phase II Study of the Efficacy and Safety of Oral Vitamin C in Combination With Azacitidine in Patients With Higher-Risk MDS, CMML-2 or Low-Blast Count AML
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
196
Start Date
2019-09-11
Completion Date
2027-12
Last Updated
2024-04-17
Healthy Volunteers
No
Interventions
Vitamin C
Oral vitamin C (ascorbic acid) 1000 mg daily will be administered from day 1 in the 1st AZA cycle (D1/C1) and continued until discontinuation of AZA or EOS as combination treatment.
Placebo
Placebo capsules (two capsules once daily) will be administered from day 1 in the 1st AZA cycle (D1/C1) and continued until discontinuation of AZA or EOS.
Locations (10)
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Herlev University Hospital
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
Zealand University Hospital
Roskilde, Denmark
Sahlgrenska University Hospital
Gothenburg, Sweden
Skåne University Hospital
Lund, Sweden
Karolinska University Hospital
Stockholm, Sweden
Uppsala University Hospital
Uppsala, Sweden