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New treatment option for Myelodysplastic Syndromes
Official title Combining Active and Passive DNA Hypomethylation
ClinicalTrials.gov ID: NCT03999723
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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)...
- Therapeutic radiation or chemotherapy within the past 6 months
- History of allergic reactions to ascorbic acid
See the full eligibility 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.
- 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...
- 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)...
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, Denmark
- Aarhus, Denmark
- Copenhagen, Denmark
- Odense, Denmark
- Roskilde, Denmark
- Gothenburg, Sweden
- Lund, Sweden
- Stockholm, Sweden
- Uppsala, Sweden
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, Denmark; Aarhus, Denmark; Copenhagen, Denmark; Odense, Denmark; Roskilde, Denmark; Gothenburg, Sweden and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.