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RecruitingAcute Myeloid Leukemia

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

Eligible age

18–75 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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.

Sponsor: Kittika Poonsombudlert

You may qualify if…

  • ✓ Adults aged ≥ 18 who are deemed unfit for intensive chemotherapy by meeting at least one of the following criteria:
  • ✓ age ≥ 75
  • ✓ Eastern Cooperative Oncology Group (ECOG) performance of 2-3
  • ✓ Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina)
  • ✓ Severe pulmonary disorder (e.g., DLCO ≤ 65% or FEV1 ≤ 65%)
  • ✓ Calculated Creatinine clearance 25 - 45 mL/min using the Cockcroft-Gault formula
  • ✓ Hepatic disorder with total bilirubin \> 1.5 times the upper limit of normal
  • ✓ Any other comorbidity that the investigators determine to be incompatible with intensive chemotherapy

You may not qualify if…

  • ✕ Patients who have received prior therapy to treat their AML (except for cytoreductive hydroxyurea or cytarabine dose ≤ 1 g/m2 for hyperleukocytosis)
  • ✕ Known hypersensitivity or allergy to ascorbate, azacitidine/decitabine, or venetoclax
  • ✕ AML patients with the following cytogenetic/molecular aberrations are not eligible i. t(8;21)(q22;q22.1)/RUNX1::RUNX1T1 ii. inv(16)(p13.1q22) or t(16;16)(p13.1;q22)/ CBFB::MYH11 iii. bZIP in-frame mutated CEBPA without any adverse mutations iv. KMT2A rearrangement v. NPM1 or IDH1 or IDH2 or FLT3-ITD or FLT3-TKD mutation
  • ✕ Patients with kidney disease needing dialysis, diabetic nephropathy, renal transplant recipients, and those with history of acute or chronic oxalate nephropathy
  • ✕ Patients with primary hemochromatosis or transfusional iron overload as defined as persistently elevated Ferritin \> 1000 ng/mL.
  • ✕ Patients with type I or type II diabetes mellitus on treatment with short acting insulin who need at least a daily blood glucose monitoring test via finger stick
  • ✕ Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
  • ✕ Other major co-morbidities as determined unsuitable per the treating physician

Where it's recruiting

Iowa

Iowa City

Source: ClinicalTrials.gov · NCT07177079 · last updated 2026-08-31

High-dose Ascorbate (HDA) in Combination With Standard of Care Azaciti · TrialPath