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High-dose Ascorbate with Azacitidine and Venetoclax for AML

This study is testing if adding high-dose ascorbate (a special intravenous form of vitamin C) to standard treatments for Acute Myeloid Leukemia (AML) is safe and effective. The standard treatments are Azacitidine (a chemotherapy drug) and Venetoclax (a targeted therapy that helps kill cancer cells). We are looking for adults aged 18 to 75 who are newly diagnosed with AML and may not be able to tolerate intensive chemotherapy. Success in this study means seeing if the combination is safe and if patients achieve a complete remission (where signs of cancer disappear). The study aims to enroll 30 participants.

Study design
This is a randomized, open-label Phase I study with an expansion phase. It will involve approximately 30 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure complete remission rates for up to three years from the start of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07177079

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

Recruiting
PHASE1Ages 18–75InterventionalTreatment
Kittika Poonsombudlert
~30 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:AzacitidineVenetoclaxHigh-dose ascorbateDecitabine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I: Dose-limiting toxicities (DLTs) according to CTCAE version 5.0
Measured over Days 1 through 28
+1 more outcome measured

Conditions

Acute Myeloid Leukemia

Explore related trials

Acute Myeloid Leukemia

Where it's being run

1 sites across 1 states
Iowa1

Study leadership

  • Kittika Poonsombudlert, MD · PRINCIPAL_INVESTIGATOR · University of Iowa

Who to contact

Kittika Poonsombudlert, MD
[email protected]
+1 319 356 1770
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Eligibility criteria

Inclusion

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 incompatible with intensive chemotherapy

Exclusion

Participants must have adequate organ function, defined as:
Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3.0 x upper limit of normal (ULN)
International normalized ratio (INR) \< 1.5 x ULN and partial thromboplastin time (PTT) \< 1.5 x ULN (patient could be eligible if they respond appropriately to correction with FFP or cryoprecipitate)
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
Patients presenting with marked leukocytosis (WBC \> 25 k/mm3) should receive cytoreduction with hydroxyurea or cytarabine dose ≤ 1 g/m2 to mitigate the risk of tumor lysis syndrome before initiation of therapy with venetoclax
For female participants of childbearing potential, a negative serum or urine pregnancy test (sensitivity of at least 25 mIU/mL) at screening
Ability to understand and the willingness to sign a written informed consent document.
Both male and female participants of childbearing potential agree to use an adequate method of contraception from screening through 6 months after the last dose of study treatment.
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
HIV-infection that is uncontrolled by anti-retroviral therapy. (HIV-infected patients on effective anti- retroviral therapy with undetectable viral load within 6 months are eligible for this study)
Patients with G6PD (glucose-6-phosphate dehydrogenase) deficiency
Patients who are on warfarin or other strong CYP3A4 inducer/inhibitor and cannot have a drug substitution or who decline the drug substitution

What this trial measures

  • Phase I: Dose-limiting toxicities (DLTs) according to CTCAE version 5.0Days 1 through 28

    As this is the first time high-dose ascorbate has been administered in combination with standard of care aza/ven, the safety of the combination will be assessed in the first 6 patients randomized to Arm B. An initial DLT assessment will be made when 3 participants have been randomized to the Investigational Arm B and are evaluable for DLTs. If at most 1 out of 3 participants experience a DLT, an additional cohort of 3 participants will be evaluated for DLTs. If at most 1 out of 6 participants experience a DLT, the combination will be deemed safe. Should greater than or equal to 2 (≥2) out of 3 or 6 participants experience a DLT, the combination will be deemed unsafe, and accrual will be terminated.

  • Expansion: Composite complete remission rate defined as the proportion of patients with a complete remission (CR or CRi)Three years from initiation of study

    The primary objective of the expansion is to estimate the composite complete remission rate defined as the proportion of patients with a complete remission (CR or CRi) by the end of study treatment for each arm separately.