Actively Recruiting
Combining Active and Passive DNA Hypomethylation
Led by Kirsten Grønbæk · Updated on 2024-04-17
196
Participants Needed
10
Research Sites
429 weeks
Total Duration
On this page
Sponsors
K
Kirsten Grønbæk
Lead Sponsor
V
Van Andel Institute - Stand Up To Cancer Epigenetics Dream Team
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Combining Active and Passive DNA Hypomethylation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients eligible for azacitidine treatment with one of the following diagnoses: higher-risk MDS (IPSS-R score > 3), CMML with 10-29% marrow blasts without myeloproliferative disorder, or AML with 20-30% blasts (low-blast count AML)
- Patients with therapy-related MDS are eligible if they have not received radiation or chemotherapy for six months
You will not qualify if you...
- Eligible for allogeneic stem cell transplantation
- Prior therapy with hypomethylating agents
- Any exclusion criterion for azacitidine treatment
- Receiving other active cancer treatments except hydroxyurea, G-CSF, or low-dose steroids (≤ 25 mg prednisolone daily) for inflammatory disorders
- Therapeutic radiation or chemotherapy within 6 months
- History of allergic reactions to ascorbic acid
- History of kidney or urinary tract stones requiring intervention within the past year
- Unable or unwilling to understand study information or sign consent
- Unwilling to comply with the study protocol
- Unwilling to stop vitamin C or multivitamin supplements at least 3 days before starting
- Planned azacitidine treatment after stem cell transplantation
- Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher
- Uncontrolled serious medical conditions including severe liver, psychiatric, neurological, metabolic, or heart diseases (NYHA class 3-4)
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Aalborg University Hospital
Aalborg, Denmark, 9100
Actively Recruiting
2
Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
3
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
4
Herlev University Hospital
Copenhagen, Denmark, 2730
Actively Recruiting
5
Odense University Hospital
Odense, Denmark, 5000
Active, Not Recruiting
6
Zealand University Hospital
Roskilde, Denmark
Terminated
7
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
8
Skåne University Hospital
Lund, Sweden
Actively Recruiting
9
Karolinska University Hospital
Stockholm, Sweden
Actively Recruiting
10
Uppsala University Hospital
Uppsala, Sweden
Actively Recruiting
Research Team
K
Kirsten Grønbæk, Prof., MD
CONTACT
K
Krista Smidt Bech, BSc, Nurse
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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