High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML)

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Kittika Poonsombudlert
Study ID
NCT07177079
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine — DRUG
    A chemotherapy drug known as a hypomethylating agent
  • Venetoclax — DRUG
    Targeted cancer therapy used to treat certain blood cancers. It specifically targets a protein called BCL-2 to trigger the self-destruction of cancer cells.
  • High-dose ascorbate — DRUG
    Administering vitamin C intravenously to achieve very high concentrations in the bloodstream. In contrast to low doses, which act as antioxidants, these pharmacological doses can function as a pro-oxidant, killing cancer cells while leaving healthy cells unharmed.
  • Decitabine — DRUG
    Azacitidine may be substituted with decitabine 20 mg/m2 daily, on days 1-5, at PI discretion in the event of toxicity/drug supply shortage.

Study Details

This is a randomized, open-label, Phase I clinical study with expansion. It will assess the safety and efficacy of high-dose ascorbate administered concomitantly with azacitidine and venetoclax in newly diagnosed AML.

Key Dates

Start date
Mar 18, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: A. Standard of Care (azacitidine and venetoclax)
    Twelve patients will be randomized to Arm A.
  • Experimental: B. High-dose ascorbate administered concomitantly with azacitidine and venetoclax
    As this is the first time high-dose ascorbate has been administered in combination with standard of care (azacitidine and venetoclax), the safety of the combination will be assessed in the first 6 patients randomized to Arm B. These patients will continue with the expansion portion of the study, and an additional 6 patients will be added for a total of 12.

Primary Outcome Measure

Phase I: Dose-limiting toxicities (DLTs) according to CTCAE version 5.0 [ Time Frame: Days 1 through 28 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Health CareIowa CityIowa52242
Kittika Poonsombudlert, MD
[email protected]
+1 319 356 1770
Kittika Poonsombudlert
[email protected]
+1 319 356 1770

Find similar trials in Iowa City, IA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Iowa Health Care· Iowa City, IA

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