High-Dose Ascorbate + Azacitidine and Venetoclax

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.

A chemotherapy drug known as a hypomethylating agent

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.

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.

Registro actualizado en ClinicalTrials.gov →

• Newly diagnosed (non-APL) acute myeloid leukemia except those with cytogenetic/molecular abnormalities in the exclusion 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%); 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; or any other comorbidity that the investigators determine to be incompatible with intensive chemotherapy
• Patients with a history of antecedent myelodysplasia (MDS) are eligible if they have not had prior chemotherapy/hypomethylating agent (e.g., azacitidine or decitabine). Prior exposure to other investigational agents could be considered at PI's discretion
• Patients who have developed therapy-related AML after prior radiation or chemotherapy for other malignancy(ies) are eligible if they have not been exposed to hypomethylating agent (e.g., azacitidine or decitabine) and/or venetoclax

Criterios de inclusión tal como figuran en el registro, recortados. La lista completa, con las exclusiones, está en el registro actualizado.