Back to search results

Ascorbate with Azacitidine for Myelodysplastic Syndrome

This study is testing if adding high-dose ascorbate (vitamin C) to azacitidine, a standard treatment, is safe and effective for adults with higher-risk myelodysplastic syndrome (MDS). MDS is a condition where the bone marrow doesn't make enough healthy blood cells. Researchers want to see if this combination improves treatment response. You may be able to join if you are 18 or older, have higher-risk MDS, and haven't had much prior MDS treatment. The study will enroll 38 participants and will look at side effects after one cycle and how well the treatment works after four cycles.

Study design
This is an open-label, Phase II study, meaning both you and the study team will know which treatments you are receiving. It will enroll 38 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will assess treatment efficacy at the end of Cycle 4 (each cycle is 28 days).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07283900

Ascorbate in Myelodysplastic Syndrome

Recruiting
PHASE2Ages 18–99InterventionalTreatment
Prajwal Dhakal
~38 participants
Updated 2026-03-16 on ClinicalTrials.gov
What's tested:High-dose ascorbateAzacitidine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose-limiting toxicities (DLTs)
Measured over At the end of Cycle 1 (each cycle is 28 days)
+1 more outcome measured

Conditions

Myelodysplastic Syndromes

Explore related trials

Myelodysplastic Syndrome

Where it's being run

1 sites across 1 states
Iowa1

Study leadership

  • Prajwal Dhakal, MD · PRINCIPAL_INVESTIGATOR · University of Iowa

Who to contact

Prajwal Dhakal, MD
[email protected]
1-319-356-4200
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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:
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.

Exclusion

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).

What this trial measures

  • Incidence of dose-limiting toxicities (DLTs)At the end of Cycle 1 (each cycle is 28 days)

    Assess the safety and tolerability of intravenous (IV) high-dose ascorbate (HDA) in combination with azacitidine.

  • Treatment EfficacyAt the end of Cycle 4 (each cycle is 28 days)

    Proportion of participants achieving a complete response (CR) or partial response (PR)