Combining Active and Passive DNA Hypomethylation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 182
Summary
- Conditions
- Acute Myeloid Leukemia
- Chronic Myelomonocytic Leukemia
- Myelodysplastic Syndromes
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A multicentre, randomized, parallel-group, placebo-controlled, double-blind phase 2 studyMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Double-blind masking (Participant, Care Provider, Investigator, (some) Outcomes Assessors)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
EVI-3 is a phase 2 international, multicentre, randomized, parallel-group, placebo-controlled, double-blind study of the efficacy and safety of oral vitamin C supplement in combination with azacitidine (AZA) in patients with higher-risk myeloid malignancies with or without mutations in genes recurre...
EVI-3 is a phase 2 international, multicentre, randomized, parallel-group, placebo-controlled, double-blind study of the efficacy and safety of oral vitamin C supplement in combination with azacitidine (AZA) in patients with higher-risk myeloid malignancies with or without mutations in genes recurrently affected in myeloid malignancies. Treatment allocation is in 1:1 ratio (vitamin C vs. placebo) by block randomization stratified by clinical site. Study entry is staggered. Patients are randomized to either oral vitamin C 1000 mg daily or placebo from start of AZA treatment until end of study (EOS) or until AZA treatment is discontinued at the discretion of the treating physician, whichever occurs earlier. The accrual time is estimated to 48 months and 6 months follow-up, thus, maximum treatment duration will be approximately 54 months. A total of 196 patients is planned for enrollment. Study visits are scheduled at baseline, after 1st AZA treatment cycle, after 6 AZA treatment cycles, and, if AZA treatment is continued, at EOS or end of AZA treatment. Evaluations at study visits include bone marrow investigation, peripheral blood tests, patient-reported outcome measures, adverse events and compliance. Bone marrow aspirate and peripheral blood will be collected for biobank at each study visit. All patients will undergo follow-up once yearly from EOS. Follow-up will include information on duration of AZA therapy, survival and disease progression from myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) to acute myeloid leukemia (AML), if diagnosed following a clinical indication for a bone marrow test.
Tracking Information
- NCT #
- NCT03999723
- Collaborators
- Skane University Hospital
- Van Andel Research Institute
- Technical University of Denmark
- Odense University Hospital
- Karolinska University Hospital
- Sahlgrenska University Hospital, Sweden
- Oslo University Hospital
- Norrland University Hospital
- Helsinki University Central Hospital
- University of Southern California
- Imperial College London
- University of Copenhagen
- Zealand University Hospital
- Uppsala University Hospital
- Aalborg University Hospital
- Aarhus University Hospital
- Investigators
- Study Director: Kirsten Grønbæk, Prof., MD Rigshospitalet, Denmark Principal Investigator: Stine Ulrik Mikkelsen, MD Rigshospitalet, Denmark Principal Investigator: Amalie B Nielsen, MD Rigshospitalet, Denmark
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