OncoMatch

OncoMatch/Clinical Trials/NCT03999723

Combining Active and Passive DNA Hypomethylation

Is NCT03999723 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for myelodysplastic syndromes.

Phase 2RecruitingKirsten GrønbækNCT03999723Data as of May 2026

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.

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Extracted eligibility criteria

Cancer type

Myelodysplastic Syndrome

Acute Myeloid Leukemia

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: hypomethylating agent

Prior therapy with hypomethylating agents

Cannot have received: radiation therapy

Exception: therapy-related MDS eligible if no radiation or chemotherapy for six months

Therapeutic radiation or chemotherapy within the past 6 months

Cannot have received: chemotherapy

Exception: therapy-related MDS eligible if no radiation or chemotherapy for six months

Therapeutic radiation or chemotherapy within the past 6 months

Lab requirements

Liver function

total serum bilirubin ≤1.5 × uln, serum alanine transaminase ≤3 × uln, no chronic hepatitis with decompensated cirrhosis

Cardiac function

no severe cardiac disease (nyha class 3-4)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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