Combining Active and Passive DNA Hypomethylation
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- STATUS
- Recruiting
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- End date
- Mar 8, 2024
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- participants needed
- 196
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- sponsor
- Kirsten Grønbæk
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.
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 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.
Details
| Condition | MYELODYSPLASTIC SYNDROME, myelodysplastic syndrome (mds), myelodysplastic syndromes, chronic myelomonocytic leukaemia, Acute myeloid leukemia, Myelodysplastic Syndromes (MDS), Bone Marrow Disorder, Acute Myeloid Leukemia, Chronic myelomonocytic leukemia, Juvenile Myelomonocytic Leukemia, acute myelogenous leukemia, anll, cmml, Acute Myelogenous Leukemia (AML), Bone marrow disorder, Preleukemia, acute myeloblastic leukemia |
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| Treatment | Placebo, Vitamin C |
| Clinical Study Identifier | NCT03999723 |
| Sponsor | Kirsten Grønbæk |
| Last Modified on | 8 October 2021 |
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