Combining vitamin C with azacitidine for treating higher-risk blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 clinical trial investigates the efficacy and safety of oral vitamin C supplementation in combination with azacitidine for patients with higher-risk myelodysplastic syndromes, acute myeloid leukemia, or chronic myelomonocytic leukemia. The study is multicenter, randomized, and double-blind, comparing vitamin C to a placebo while patients receive azacitidine treatment. Participants will be monitored through various evaluations, including bone marrow investigations and patient-reported outcomes, over a treatment duration of approximately 54 months. The goal is to determine if vitamin C can enhance the effectiveness of azacitidine in these patients.

Why it matters

Who can join: the full rules

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)

Where it's running

• 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

Study contacts

• Principal investigator: Stine Ulrik Mikkelsen, MD, PhD — Copenhagen University Hospital, Rigshospitalet
• Study coordinator: Kirsten Grønbæk, Prof., MD
• Email: kirsten.groenbaek@regionh.dk
• Phone: +45 35 45 60 86

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.