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Vitamin
High-Dose Vitamin C for Myelodysplastic Syndrome
Phase 1 & 2
Waitlist Available
Led By Mohammad M Abdul Hay, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if giving high doses of Vitamin C to patients with a specific blood disorder and genetic mutation is safe and beneficial. The goal is to see if it helps improve their blood and bone marrow conditions.
Who is the study for?
This trial is for adults with Myelodysplastic Syndrome at intermediate or high risk, who have TET2 mutations. They must have adequate liver and kidney function, a certain level of blood cells, and be able to consent. Pregnant women can't join; neither can those with recent cancers (except some skin/breast/cervical), severe infections, major surgery within 2 weeks, HIV/Hepatitis B/C, poor lung function or heart issues.
What is being tested?
The study tests high-dose Vitamin C infusion therapy's safety and effects on bone marrow/blood in patients with specific genetic changes in their MDS. It's an early-phase trial where everyone gets the same treatment: Vitamin C infusions for five days every four weeks.
What are the potential side effects?
Potential side effects may include digestive discomfort due to high vitamin doses, possible increased risk of kidney stones for those predisposed to them because Vitamin C can increase oxalate levels in urine which might lead to stone formation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Patients Who Experienced a Dose Limiting Toxicity (DLT)
Side effects data
From 2020 Phase 2 trial • 34 Patients • NCT0190515021%
Nausea
14%
Fatigue
14%
Depression
14%
Diarrhea
14%
Pain
14%
Anxiety
7%
Anemia
7%
Ascites
7%
Insomnia
100%
80%
60%
40%
20%
0%
Study treatment Arm
G-FLIP Alone for 4 Weeks, Then G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+VitaminC
G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+Vitamin C.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Vitamin C 75 gExperimental Treatment1 Intervention
Patients will receive Vitamin C as a continuous intravenous infusion (CIVI) of 75 grams (g) daily over 24 hours for 5 days for total of 375 grams over 5 days.
Group II: Vitamin C 50 gExperimental Treatment1 Intervention
Patients will receive Vitamin C as a continuous intravenous infusion (CIVI) of 50 grams (g) daily over 24 hours for 5 days for total of 250 grams over 5 days up.
Group III: Vitamin C 100 gExperimental Treatment1 Intervention
Patients will receive Vitamin C as a continuous intravenous infusion (CIVI) of 100 grams (g) daily over 24 hours for 5 days for total of 500 grams over 5 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin C
2017
Completed Phase 4
~18470
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
High-dose Vitamin C is being studied for its ability to modulate TET2 enzyme activity, which is important for DNA demethylation and normal hematopoiesis. This is particularly relevant for MDS patients with TET2 mutations, as it may help restore normal blood cell production.
Hypomethylating agents like azacitidine and decitabine work by inhibiting DNA methylation, thereby reactivating tumor suppressor genes and promoting normal cell differentiation. Erythropoiesis-stimulating agents (ESAs) increase red blood cell production by stimulating the bone marrow.
These treatments are crucial for MDS patients as they address the underlying genetic and epigenetic abnormalities, improving blood counts and reducing the need for transfusions.
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,403 Previous Clinical Trials
855,122 Total Patients Enrolled
Perlmutter Cancer CenterUNKNOWN
Mohammad M Abdul Hay, MDPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have not received any cancer treatment for the past two weeks, except for supportive care measures.You have a past medical history of G6PD deficiency, hereditary spherocytosis, or hemochromatosis.You have severe heart problems, such as unstable angina or congestive heart failure, that are not well controlled. You have had a heart attack or stroke within the past 6 months. You also have significant and uncontrolled irregular heartbeats.You have a history of kidney stones or other kidney problems.You have a serious illness that is not under control.If you are already taking hypomethylating agents, you can still join the study and receive vitamin C treatment at the same time.You are currently taking or have previously taken certain medications that stimulate the production of red blood cells or white blood cells.
Research Study Groups:
This trial has the following groups:- Group 1: Vitamin C 75 g
- Group 2: Vitamin C 100 g
- Group 3: Vitamin C 50 g
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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