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Clinical Trials in Denmark / NCT03999723
Recruiting Phase 2

Combining Active and Passive DNA Hypomethylation

NCT03999723 · tracked via the Priya Life Science Denmark tracker
Sponsor
Kirsten Grønbæk
Phase
Phase 2
Started
2019-09-11
Last updated
2024-04-17

Condition(s) studied

Myelodysplastic SyndromesAcute Myeloid LeukemiaChronic Myelomonocytic Leukemia

Investigational drug(s) / intervention(s)

Vitamin CPlacebo

Vitamin C: Oral vitamin C (ascorbic acid) 1000 mg daily will be administered from day 1 in the 1st AZA cycle (D1/C1) and continued until discontinuation of AZA or EOS as combination treatment.

Placebo: Placebo capsules (two capsules once daily) will be administered from day 1 in the 1st AZA cycle (D1/C1) and continued until discontinuation of AZA or EOS.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
Aalborg University Hospital Aalborg Denmark Recruiting
Aarhus University Hospital Aarhus Denmark Recruiting
Rigshospitalet Copenhagen Denmark Recruiting
Herlev University Hospital Copenhagen Denmark Recruiting
Odense University Hospital Odense Denmark Active Not Recruiting
Zealand University Hospital Roskilde Denmark Terminated
Sahlgrenska University Hospital Gothenburg Sweden Recruiting
Skåne University Hospital Lund Sweden Recruiting
Karolinska University Hospital Stockholm Sweden Recruiting
Uppsala University Hospital Uppsala Sweden Recruiting

More Kirsten Grønbæk trials in Denmark

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03999723 on ClinicalTrials.gov ↗ ← All trials in Denmark