NCT03999723 Combining Active and Passive DNA Hypomethylation
| NCT ID | NCT03999723 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Kirsten Grønbæk |
| Condition | Myelodysplastic Syndromes |
| Study Type | INTERVENTIONAL |
| Enrollment | 196 participants |
| Start Date | 2019-09-11 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 196 participants in total. It began in 2019-09-11 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
Kirsten Grønbæk, Prof., MD
STUDY DIRECTOR
Rigshospitalet, Denmark
Frequently Asked Questions
Who can join the NCT03999723 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myelodysplastic Syndromes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03999723 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03999723 currently recruiting?
Yes, NCT03999723 is actively recruiting participants. Contact the research team at kirsten.groenbaek@regionh.dk for enrollment information.
Where is the NCT03999723 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus, Denmark, Copenhagen, Denmark, Copenhagen, Denmark and 6 additional locations.
Who is sponsoring the NCT03999723 clinical trial?
NCT03999723 is sponsored by Kirsten Grønbæk. The principal investigator is Kirsten Grønbæk, Prof., MD at Rigshospitalet, Denmark. The trial plans to enroll 196 participants.