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Combining Active and Passive DNA Hypomethylation

Study acronym: EVI-3
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 17, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Sep 2024 to Dec 2025
    • Study sites: 6 to 10
    • Study completion date: Sep 2027 to Dec 2027
    v7
  2. Primary completion date: Mar 2024 to Sep 2024v6 Show 4 more changesShow less
    • Study completion date: Mar 2024 to Sep 2027
    • Eligibility criteria expanded, about 76 words
    • Secondary endpoints: details revised at 2 of 10 entries
    • Collaborators: 16 to 13
  3. Primary and study completion dates: Sep 2023 to Mar 2024
    • Site details revised at 2 of 6 sites
    v5
  4. Primary endpoint revisedv4 Show 6 more changesShow less
    • Enrollment target: 182 to 196
    • Study sites: 4 to 6
    • Primary and study completion dates: Mar 2023 to Sep 2023
    • Secondary endpoints: 9 to 10
    • Study description expanded, about 9 words
    • Collaborators revised (16)
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 4
    • Primary and study completion dates: Feb 2023 to Mar 2023
    • Start date changed from estimate of Aug 26, 2019 to Sep 11, 2019
    v3
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03999723
Lead Sponsor Kirsten Grønbæk
Collaborators: Van Andel Institute - Stand Up To Cancer Epigenetics Dream Team, Karolinska University Hospital, Skane University Hospital, Sahlgrenska University Hospital, University of Southern California, Imperial College London, University of Copenhagen, Zealand University Hospital, Aalborg University Hospital, Odense University Hospital, Technical University of Denmark, Aarhus University Hospital, Uppsala University Hospital
Conditions
(from sponsor)		 Myelodysplastic Syndromes, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia
Related terms Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Chronic, Myelodysplastic Syndromes
Enrollment 196 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov