Testing Vitamin C With Azacitidine for Blood Cancers of the Bone Marrow
Tests vitamin C with azacitidine in adults with higher-risk myelodysplastic syndromes or leukemia.
Plain-language title generated from the registry record
Registry title: Combining Active and Passive DNA Hypomethylation
Key facts
- Where
- Aalborg, Aarhus, Copenhagen, Odense, and Roskilde, DenmarkSee the 6 sites
- Phase
- Phase 2
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkTaking people
- Aarhus University HospitalAarhus, DenmarkTaking people
- Herlev University HospitalCopenhagen, DenmarkTaking people
- RigshospitaletCopenhagen, DenmarkTaking people
- Odense University HospitalOdense, DenmarkNo longer taking part
- Zealand University HospitalRoskilde, DenmarkNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kirsten Grønbæk
- Trial code
- NCT03999723
- Record updated
- 17 April 2024
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Patients eligible for treatment with azacitidine with one of the following diagnoses according to World Health Organization 2016:; 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); Note: Patients with therapy-related MDS are eligible if they have not received radiation or chemotherapy for six months.
Exclusion: Patient eligible for allogeneic stem cell transplantation; Prior therapy with hypomethylating agents; Any matter constituting an exclusion criterion for treatment with azacitidine; Therapeutic radiation or chemotherapy within the past 6 months; Unwillingness to discontinue any and all use of vitamin C medication/supplementation including multivitamin at least 3 days (but preferably longer) prior to inclusion and baseline sampling; Planned azacitidine treatment after allogeneic stem cell transplantation; History of allergic reactions to ascorbic acid; History of kidney or urinary tract stones requiring intervention within the past year; 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; Uncontrolled comorbidity including impaired hepatic function (total serum bilirubin >1.5 × upper limit of the normal range (ULN), serum alanine transaminase >3 × ULN, chronic hepatitis with decompensated cirrhosis), disabling psychiatric disease, severe neurologic disease, severe metabolic disease, or severe cardiac disease (NYHA class 3-4); Lack of ability to understand the information given, or lack of willingness to sign a written informed consent document; Unwillingness to comply with the protocol; Eastern Cooperative Oncology Group (ECOG) performance status ≥3.