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Recruiting Phase 2

Combining Active and Passive DNA Hypomethylation

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About this study

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.

Condition
Myelodysplastic Syndromes, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia
Tested
Vitamin C, Placebo
Sponsor
Kirsten Grønbæk

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 7

  • Minimum age: 18 years
  • Study condition: Myelodysplastic Syndromes, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia
  • 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 13

  • 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)

Where

10 sites, 8 recruiting

Aalborg University Hospital

Aalborg, Denmark

Recruiting

Aarhus University Hospital

Aarhus, Denmark

Recruiting

Rigshospitalet

Copenhagen, Denmark

Recruiting

Herlev University Hospital

Copenhagen, Denmark

Recruiting

Sahlgrenska University Hospital

Gothenburg, Sweden

Recruiting

Skåne University Hospital

Lund, Sweden

Recruiting

and 4 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.