Combining Active and Passive DNA Hypomethylation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKirsten Grønbæk
About this trial
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.
Eligibility criteria
Qualifiers
MDS Higher-risk MDS according to the IPSS-R, i.e., intermediate- to very high-risk (IPSS-R score > 3)
CMML CMML with 10-29 percent marrow blasts without myeloproliferative disorder
AML AML with 20-30 percent blasts (low-blast count AML)
Disqualifiers
Patient eligible for allogeneic stem cell transplantation
Prior therapy with hypomethylating agents
Any matter constituting an exclusion criterion for treatment with azacitidine
Patient receiving other active cancer treatment, including investigational agents, with the exception of hydroxyurea for white blood cell (WBC) control, G-CSF, and low permanent doses of steroid (≤ 25 mg oral prednisolone per day) for inflammatory disorders
Trial design
Treatments tested in this trial
- Vitamin C
- Placebo
Treatment groups
196 Participants
are divided into 2 treatment groupsSponsors and collaborators
Kirsten Grønbæk
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Van Andel Institute - Stand Up To Cancer Epigenetics Dream Team
Collaborator
Karolinska University Hospital
Collaborator
Skane University Hospital
Collaborator
Sahlgrenska University Hospital
Collaborator
University of Southern California
Collaborator
Imperial College London
Collaborator
University of Copenhagen
Collaborator
Zealand University Hospital
Collaborator
Aalborg University Hospital
Collaborator
Odense University Hospital
Collaborator
Technical University of Denmark
Collaborator
Aarhus University Hospital
Collaborator
Uppsala University Hospital
Collaborator
Source ClinicalTrials.gov