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Combining Active and Passive DNA Hypomethylation

RecruitingPhase 2Ages 18 Years - anyAllKirsten Grønbæk
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 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 Criteria: * 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 * Therapeutic radiation or chemotherapy within the past 6 months * History of allergic reactions to ascorbic acid * History of kidney or urinary tract stones requiring intervention within the past year * 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 * 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 * Eastern Cooperative Oncology Group (ECOG) performance status ≥3 * 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)
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What it tests

  • Vitamin C
  • Placebo
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Where

10 sites
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

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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