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New treatment option for Myelodysplastic Syndromes
Official title Ascorbate in Myelodysplastic Syndrome
ClinicalTrials.gov ID: NCT07283900
What this study is testing
What is High-dose ascorbate?
High-dose ascorbate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for myelodysplastic syndromes.
Also referred to as Vitamin C.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, phase II clinical trial with safety run-in evaluating the safety, tolerability, and efficacy of IV HDA in combination with azacitidine for participants with MDS.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Age ≥ 18 years.
- Diagnosis of myelodysplastic syndrome (MDS) requiring treatment with a hypomethylating agent (HMA).
- Higher-risk MDS per the Molecular International Prognostic Scoring System (IPSS-M) - Moderate High, High, or Very High risk categories.
- No prior MDS-directed therapy, except: ≤ 1 prior cycle of azacitidine, decitabine, or oral decitabine-cedazuridine; or prior use of ESA...
- ECOG performance status 0-2.
You likely can't join if
- MDS with isolated del(5q) eligible for lenalidomide therapy.
- MDS/MPN overlap syndromes other than MDS.
- Known hypersensitivity or allergy to ascorbate or azacitidine.
- Pregnant or nursing individuals.
- Inability or unwillingness to use adequate contraception.
- Uncontrolled intercurrent illness including active infection, recent myocardial infarction (≤6 months), uncontrolled heart failure or arrhythmia...
See the full eligibility criteria
- Age ≥ 18 years.
- Diagnosis of myelodysplastic syndrome (MDS) requiring treatment with a hypomethylating agent (HMA).
- Higher-risk MDS per the Molecular International Prognostic Scoring System (IPSS-M) - Moderate High, High, or Very High risk categories.
- No prior MDS-directed therapy, except: ≤ 1 prior cycle of azacitidine, decitabine, or oral decitabine-cedazuridine; or prior use of ESA, luspatercept, or imetelstat. Prior hydroxyurea use is allowed but continuation...
- ECOG performance status 0-2.
- Adequate organ function: Creatinine clearance \>45 mL/min; total bilirubin ≤1.5 × ULN; ALT and AST ≤3 × ULN.
- Ability to provide written informed consent.
- Willingness to comply with study visits, treatment, and contraception requirements.
- Negative pregnancy test for women of childbearing potential at screening.
- MDS with isolated del(5q) eligible for lenalidomide therapy.
- MDS/MPN overlap syndromes other than MDS.
- Known hypersensitivity or allergy to ascorbate or azacitidine.
- Pregnant or nursing individuals.
- Inability or unwillingness to use adequate contraception.
- Uncontrolled intercurrent illness including active infection, recent myocardial infarction (≤6 months), uncontrolled heart failure or arrhythmia, pulmonary edema, unstable angina, or significant psychiatric illness.
- Renal disease requiring dialysis, diabetic nephropathy, renal transplant recipients, or history of oxalate nephropathy.
- Paroxysmal nocturnal hemoglobinuria.
- Uncontrolled HIV infection (patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible).
- G6PD deficiency.
- Use of warfarin (due to potential interaction with high-dose ascorbate).
- Diabetic patients using fingerstick or continuous glucose monitors to adjust insulin doses (ascorbate can cause false readings).
- Concurrent active malignancy, except adequately treated nonmelanoma skin cancer or curatively treated in situ cancers with \>2 years disease-free.
- Systemic immunosuppressive therapy with prednisone ≥20 mg/day (or equivalent), except for inhaled or topical steroids.
- Primary hemochromatosis or transfusion-related iron overload (ferritin \>1000 ng/mL).
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.