Vitamin c boost: could high doses help treat a tough blood cancer?
NCT ID NCT07177079
First seen Jun 25, 2026 · Last updated Sep 01, 2026 · Updated 3 times
Summary
This early-stage trial is testing whether adding high-dose vitamin C (given through an IV) to the usual two-drug combination (azacitidine and venetoclax) is safe and effective for people newly diagnosed with acute myeloid leukemia who cannot handle intensive chemotherapy. About 30 adults aged 18 and older who are considered unfit for standard intensive treatment will take part. The study first checks for serious side effects, then looks at how many patients achieve complete remission.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- High-dose vitamin C (ascorbate) given intravenously, plus azacitidine and venetoclax
- What this could lead to
- If it works, this could point toward a more effective and tolerable treatment option for older or frail adults with acute myeloid leukemia.
- What could go wrong
- This is a very early phase 1 trial with only 30 participants, so safety and effectiveness are not yet proven. The high-dose vitamin C may cause side effects or fail to improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2026
- Expected to finish
-
Dec 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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%) * 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 * Any other comorbidity that the investigators determine to be incompatible with intensive chemotherapy * Newly diagnosed (non-APL) acute myeloid leukemia except those with cytogenetic/molecular abnormalities in the 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) * 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 with evidence of Central Nervous System (CNS) disease involvement or who are at high risk of developing CNS disease at baseline/screening (defined as: presenting WBC \> 200k/mm3, or monocytic differentiation or active CSN symptoms concerning CNS involvement per the treating physician) are eligible for this trial and may continue to receive or initiate intrathecal chemotherapy as treatment or prophylaxis, respectively, per institutional practice Exclusion Criteria * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute myeloid leukemia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
University of Iowa Health Care
RECRUITINGIowa City, Iowa, 52242, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an HDAC inhibitor wipe out residual leukemia cells?
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Two-Drug combo targets leukemia that outsmarted its first treatment
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Can a drug and donor cells stop leukemia from returning after transplant?
- New drug combination targets Hard-to-Treat blood cancers