Actively Recruiting
High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML)
Led by Kittika Poonsombudlert · Updated on 2026-04-09
30
Participants Needed
1
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older who are considered unfit for intensive chemotherapy by meeting at least one of the following: age 75 or older, ECOG performance status of 2-3, severe cardiac disorder, severe pulmonary disorder, creatinine clearance less than 45 mL/min, hepatic disorder with bilirubin above 1.5 times normal, or other comorbidities incompatible with intensive chemotherapy
- Newly diagnosed non-APL acute myeloid leukemia except those with specified cytogenetic/molecular abnormalities
- Adequate organ function defined as AST and ALT less than or equal to 3 times the upper limit of normal, INR and PTT less than 1.5 times upper limit of normal (correctable with treatment if needed)
- History of myelodysplasia allowed if no prior chemotherapy or hypomethylating agents used
- Therapy-related AML allowed if no prior hypomethylating agents or venetoclax exposure
- Patients with high white blood cell count must receive cytoreduction before starting venetoclax
- Negative pregnancy test for women of childbearing potential
- Ability and willingness to provide informed consent
- Agreement to use adequate contraception from screening through 6 months after last study treatment
You will not qualify if you...
- Prior therapy for AML except for hydroxyurea or low-dose cytarabine for hyperleukocytosis
- Known allergy to ascorbate, azacitidine/decitabine, or venetoclax
- AML with specific cytogenetic/molecular abnormalities including t(8;21), inv(16), bZIP mutated CEBPA without adverse mutations, KMT2A rearrangement, or mutations in NPM1, IDH1, IDH2, FLT3-ITD, or FLT3-TKD
- Kidney disease requiring dialysis, diabetic nephropathy, renal transplant, or history of oxalate nephropathy
- Primary hemochromatosis or transfusional iron overload with ferritin > 1000 ng/mL
- Diabetes on short-acting insulin requiring daily glucose monitoring
- Prior or concurrent malignancy that may interfere with safety or efficacy assessments
- Other major comorbidities deemed unsuitable by physician
- Uncontrolled HIV infection
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Use of warfarin or strong CYP3A4 inducers/inhibitors without possible substitution or refusal of substitution
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
Actively Recruiting
Research Team
K
Kittika Poonsombudlert, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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