High-dose Ascorbate + Azacitidine for Myelodysplastic Syndrome
(AIMS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of high-dose vitamin C (ascorbate) and azacitidine (a hypomethylating agent) to determine its safety and effectiveness for people with myelodysplastic syndrome (MDS), a condition where the bone marrow doesn’t produce enough healthy blood cells. The trial focuses on those with a higher risk of MDS who require treatment with hypomethylating agents. Individuals diagnosed with MDS and with minimal prior treatment may be suitable candidates for this trial. Participants will receive both treatments in a 28-day cycle to evaluate their combined effectiveness. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot use warfarin or high doses of prednisone. If you're on hydroxyurea, you may need approval to continue beyond the first cycle.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that azacitidine is generally safe and effective for treating myelodysplastic syndrome (MDS) and has been proven to help patients live longer. Some studies have explored different methods of administering azacitidine, and it has been combined with other treatments without major issues.
The combination of high-dose vitamin C with azacitidine remains under investigation, with hopes of improving treatment outcomes. Although limited information exists on the safety of using high-dose vitamin C with azacitidine, the study's progression to Phase 2 indicates some safety has been demonstrated in earlier stages.
In summary, azacitidine is already used for MDS, and researchers are testing whether adding high-dose vitamin C can safely enhance its effects. Participants will be closely monitored to manage any side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of high-dose ascorbate and azacitidine for treating Myelodysplastic Syndrome (MDS) because it introduces a novel approach by combining a high dose of vitamin C (ascorbate) with a chemotherapy agent (azacitidine). Unlike standard treatments that primarily focus on altering the bone marrow environment, this combination aims to enhance the cancer-fighting potential of azacitidine by leveraging the oxidative properties of high-dose ascorbate. This approach could potentially improve treatment efficacy by targeting the cancer cells more aggressively, offering hope for better patient outcomes in MDS.
What evidence suggests that this treatment might be an effective treatment for myelodysplastic syndrome?
Research has shown that azacitidine can help treat myelodysplastic syndrome (MDS). In previous studies, about 38% of patients experienced improved blood counts after using azacitidine. High-dose vitamin C may aid by promoting normal blood cell development and eliminating harmful cells, as early lab tests observed. In this trial, all participants will receive a combination of high-dose ascorbate and azacitidine to improve the overall response in treating MDS.16789
Who Is on the Research Team?
Prajwal Dhakal, MD
Principal Investigator
University of Iowa
Are You a Good Fit for This Trial?
This trial is for individuals with Myelodysplastic Syndrome (MDS). Specific eligibility criteria are not provided, but typically participants must meet certain health conditions and agree to the treatment protocol.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-in
Initial phase to assess the safety and tolerability of the treatment combination
Treatment
Participants receive high-dose intravenous ascorbate and azacitidine in 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Azacitidine
- High-dose ascorbate
Trial Overview
The study tests high-dose intravenous ascorbate (vitamin C) combined with azacitidine in patients with MDS. It's an open-label, phase II trial focusing on safety, tolerability, and how well the treatment works.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All participants receive the combination of high-dose intravenous ascorbate (75 g on days 1, 3, 5, and 7) and azacitidine (75 mg/m² intravenous or subcutaneous on days 1-7) in 28-day treatment cycles.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Prajwal Dhakal
Lead Sponsor
Citations
NCT07283900 | Ascorbate in Myelodysplastic Syndrome
It aims to determine whether adding high-dose ascorbate can safely enhance the therapeutic response to azacitidine, a standard hypomethylating ...
Ascorbate in Myelodysplastic Syndrome
This outcome measure will evaluate participants' overall quality of life, functional status, and symptom burden at various time points throughout the study.
Oral vitamin C supplementation to patients with myeloid ...
Both studies show that vitamin C can normalize myeloid differentiation and induce cell death [19, 20]. In vitro studies of solid cancers have ...
4.
ashpublications.org
ashpublications.org/bloodadvances/article/6/9/2854/483953/Historical-expectations-with-DNA-methyltransferaseHistorical expectations with DNA methyltransferase inhibitor ...
More patients treated with azacitidine achieved HI (38%; 95% CI, 0.35-0.41) compared with decitabine (15%; 95% CI, 0.13-0.19), whereas the ...
Myelodysplastic Syndromes: Recent Advancements in Risk ...
In patients with higher-risk MDS, encouraging results of combining azacitidine (75 mg/m2 day 1 through 5 every 28 days) with lenalidomide (10 mg daily day 1 ...
6.
trial.medpath.com
trial.medpath.com/clinical-trial/4f292b7421d185f2/nct07283900-ascorbate-azacitidine-myelodysplastic-syndromeAscorbate in Myelodysplastic Syndrome | MedPath
This is an open-label, phase II clinical trial with safety run-in evaluating the safety, tolerability, and efficacy of IV HDA in combination with azacitidine ...
Safety and efficacy of azacitidine in myelodysplastic ...
Azacitidine has been reported to prolong survival in MDS patients. Azacitidine has been studied in different dosing schedules and combination therapies with the ...
Phase II trial assessing safety and preliminary efficacy of ...
Patients with TET2 mutant (TET2MT) CCUS have a high probability of progression to myeloid neoplasms, with approximated 10-year cumulative rates ...
9.
hematologyadvisor.com
hematologyadvisor.com/reports/myelodysplastic-syndrome-mds-azacitidine-improve-outcomes-treatment/5-Day Azacitidine May Improve Outcomes Compared With ...
Multivariate analysis among patients with transfusion-dependence suggested that 5-day azacitidine improved OS outcomes compared with 3-day ...
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