Ascorbate in Myelodysplastic Syndrome

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Prajwal Dhakal
Study ID
NCT07283900
Phase
PHASE2
Status
Recruiting
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Conditions

  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • High-dose ascorbate — DRUG
    Ascorbate, or vitamin C, is a water-soluble vitamin with antioxidant properties that also functions as a cofactor for several enzymatic reactions, including collagen synthesis and the activity of dioxygenase enzymes involved in DNA and histone demethylation
  • Azacitidine — DRUG
    Azacitidine is a pyrimidine nucleoside analog of cytidine that incorporates into RNA and DNA, inhibiting DNA methyltransferase and leading to global DNA hypomethylation

Study Details

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.

Key Dates

Start date
Mar 11, 2026
Status verified
Mar 2026
Primary completion
May 1, 2028
Completion
May 1, 2029

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: High-Dose Ascorbate + Azacitidine
    All participants receive the combination of high-dose intravenous ascorbate (75 g on days 1, 3, 5, and 7) and azacitidine (75 mg/m² intravenous or subcutaneous on days 1-7) in 28-day treatment cycles.

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242-

Find similar trials in Iowa City, IA

By research site
University of Iowa· Iowa City, IA

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