Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT03999723
PHASE2

Combining Active and Passive DNA Hypomethylation

Sponsor: Kirsten Grønbæk

View on ClinicalTrials.gov

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

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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