Combining Active and Passive DNA Hypomethylation
Recruiting
Phase 2
Interventional Study
Myelodysplastic Syndromes
Acute Myeloid Leukemia
Chronic Myelomonocytic Leukemia
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 196 (estimated)
- Sponsor
- Kirsten Grønbæk · Other
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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 effecti…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
• 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 bla…
Contacts