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

NOT_YET_RECRUITINGPHASE1

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

High-dose Ascorbate (HDA) in Combination With Azacitidine and Venetoclax (Aza/Ven) in Newly Diagnosed Acute Myeloid Leukemia (AML)

NCT07177079•Kittika Poonsombudlert

View on ClinicalTrials.gov

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.

Detailed 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

18 - 75 years

Sex

ALL

Healthy Volunteers

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 incompatible with intensive chemotherapy
•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
+2 more criteria

Exclusion Criteria

•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)
•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
•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)
+2 more criteria

Locations (1)

University of Iowa Health Care

Iowa City, Iowa, United States

Key Dates

Start Date

May 31, 2026

Primary Completion Date

December 31, 2028

Completion Date

December 31, 2029

Last Updated

February 23, 2026

Enrollment

ESTIMATED participants

Conditions

Acute Myeloid Leukemia

Interventions

Azacitidine

DRUG

Venetoclax

DRUG

High-dose ascorbate

DRUG

Decitabine

DRUG

Contacts

Kittika Poonsombudlert, MD

CONTACT

+1 319 356 1770 kittika-poonsombudlert@uiowa.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

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