High-dose Ascorbate (HDA) in Combination With Azacitidine and Venetoclax (Aza/Ven) in Newly Diagnosed Acute Myeloid Leukemia (AML)
Kittika Poonsombudlert
Summary
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.
Description
The purpose of this research study is to see if adding high dose ascorbate (vitamin c) intravenous infusion (IV) to the standard treatment regimen for AML (azacitidine/venetoclax or decitabine/venetoclax) is safe, and also to see if the addition of high dose ascorbate enhances the anti-AML impact of the azacitidine given with standard care.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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%) * Creatinine clearance \< 45 mL/min * Hepatic disorder with total bilirubin \> 1.5 times the upper limit of normal * Any other comorbidity that the investigators determine to be inco…
Interventions
- DrugAzacitidine
A chemotherapy drug known as a hypomethylating agent
- DrugVenetoclax
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.
- DrugHigh-dose ascorbate
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.
- DrugDecitabine
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.
Location
- University of Iowa Health CareIowa City, Iowa