Actively Recruiting
Ascorbate in Myelodysplastic Syndrome
Led by Prajwal Dhakal · Updated on 2026-03-16
38
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ascorbate in Myelodysplastic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of myelodysplastic syndrome requiring treatment with a hypomethylating agent
- Higher-risk MDS classified as Moderate High, High, or Very High risk by IPSS-M
- No prior MDS treatment except up to 1 cycle of azacitidine, decitabine, or oral decitabine-cedazuridine, or prior use of ESA, luspatercept, or imetelstat
- ECOG performance status between 0 and 2
- Adequate organ function with creatinine clearance greater than 45 mL/min, total bilirubin at or below 1.5 times the upper limit of normal, and ALT/AST at or below 3 times the upper limit of normal
- 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
You will not qualify if you...
- MDS with isolated del(5q) eligible for lenalidomide therapy
- MDS/myeloproliferative neoplasm 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 illness including active infection, recent myocardial infarction within 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 (except patients on effective therapy with undetectable viral load within 6 months)
- G6PD deficiency
- Use of warfarin due to potential interaction with high-dose ascorbate
- Diabetic patients using glucose monitors to adjust insulin doses
- Concurrent active cancers except treated nonmelanoma skin cancer or curatively treated in situ cancers with more than 2 years disease-free
- Systemic immunosuppressive therapy with prednisone 20 mg/day or higher, except inhaled or topical steroids
- Primary hemochromatosis or transfusion-related iron overload with ferritin over 1000 ng/mL
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
Research Team
P
Prajwal Dhakal, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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