A Phase 1/2 interventional study of Vitamin C in Myelodysplastic Syndromes, sponsored by NYU Langone Health. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-27.
Sponsored by NYU Langone Health · Phase 1/2, Interventional, and Treatment
Among 10 studies testing Ascorbic Acid in Myelodysplastic Syndromes — 1 open to participants now, 2 under way, none of them phase 3. Ascorbic Acid · Myelodysplastic Syndromes.
Among the 10 studies testing Ascorbic Acid in Myelodysplastic Syndromes, this one is the 10th largest by enrollment, is one of 2 that started in 2018, is the only one in phase 1/2, and was the 7th registered.
1,997 studies on the registry are indexed under Myelodysplastic Syndromes; 324 are open to participants now.
Browse Myelodysplastic Syndromes studies →1 of the 10 studies testing Ascorbic Acid in Myelodysplastic Syndromes is open now, in 2 countries. Recruiting first, the newest first:
Kirsten Grønbæk · Sites in Denmark, Sweden
Ages 18+
By country, each count listing its studies:
Ascorbic Acid: first FDA approval 1947 (BEROCCA PN). What it is approved for, and how studies give it, is on its page →
Of the 262 Myelodysplastic Syndromes studies recruiting now, 165 (63%) set no upper age limit and 70 (27%) stop at 75 or younger; 57 take children under 18; 17 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 8
First in 1998; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 4 is below the median of 40 across 1,611 interventional studies indexed under Myelodysplastic Syndromes.
Median enrollment 23 across the 10 interventional studies. Of the 6 that completed or were terminated, 2 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 10 has an industry lead sponsor. The 8 most frequent:
NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
NYU Langone Health has 3 studies filed under Myelodysplastic Syndromes — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies testing Ascorbic Acid in Myelodysplastic Syndromes, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is an open label, Phase Ib study designed to evaluate the safety, toxicity and biological activity of high dose Vitamin C in bone marrow and peripheral blood when administered as therapy to patients with intermediate or high risk myelodysplastic syndrome according to the revised IPSS (international prognostic scoring system) criteria whose disease has a Ten-eleven translocation-2, (TET2) mutation. The primary objectives phase 1 study is to establish safety and confirm a steady level of Vitamin C on ≥1 mM in > 75% of the patients is achieved. All patients will receive at least 1 cycle of treatment (4 weeks). Patients with clinical benefit (CR,PR, or SD) then will undergo a second 4-week cycle of treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate organ function
Exclusion Criteria:
Any significant medical conditions, laboratory abnormality, or psychiatric illness that would exclude the subject from participation or interfere with study treatment, monitoring and compliance such as:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Vitamin C
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.
Drug: Vitamin C
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.
Drug: Vitamin C
All patients will receive at least 1 cycle of treatment (4 weeks) of Vitamin C as a continuous intravenous infusion (CIVI). Patients with clinical benefit (CR, PR, or SD) then will undergo a second 4-week cycle of treatment. Patients to receive a maximum of 16 weeks of treatment (4 cycles). If a patient progress after receiving a cycle of treatment then the patient will be withdrawn from the study. Patients will be maintained on 1 gram oral Vitamin C daily from the end of the CIVI until the beginning of the next cycle (from day 6 till 28).
Also known as: ascorbic acid, ascorbate
Number of Patients Who Experienced a Dose Limiting Toxicity (DLT)
DLT is defined as grade 3 or higher of any duration or as a Grade ≥2 adverse event (AE) that persists for ≥96 hours with the exception of Grade ≥ 2 AEs clearly related to the underlying MDS
Time frame: Week 16
| Milestone | Vitamin C 50 g | Vitamin C 75 g | Vitamin C 100 g |
|---|---|---|---|
| Started | 1 | 3 | 0 |
| Completed | 0 | 2 | 0 |
| Not completed | 1 | 1 | 0 |
| Withdrew: Progression of disease | 1 | 0 | 0 |
| Withdrew: Physician decision | 0 | 1 | 0 |
DLT is defined as grade 3 or higher of any duration or as a Grade ≥2 adverse event (AE) that persists for ≥96 hours with the exception of Grade ≥ 2 AEs clearly related to the underlying MDS
| Participants | Vitamin C 50 g | Vitamin C 75 g | Vitamin C 100 g |
|---|---|---|---|
| Number of Patients Who Experienced a Dose Limiting Toxicity (DLT) | 0 | 0 | 0 |
Collected over 4 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vitamin C 50 g | 0/1 (0%) | 1/1 (100%) | 1/1 (100%) |
| Vitamin C 75 g | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Vitamin C 100 g | — | — | — |
| Event | Vitamin C 50 g | Vitamin C 75 g | Vitamin C 100 g |
|---|---|---|---|
| PancytopeniaBlood and lymphatic system disorders | 1/1 | 0/3 | — |
| Pain in ExtremityMusculoskeletal and connective tissue disorders | 1/1 | 0/3 | — |
| Catheter Related InfectionInfections and infestations | 1/1 | 0/3 | — |
| Event | Vitamin C 50 g | Vitamin C 75 g | Vitamin C 100 g |
|---|---|---|---|
| AnemiaBlood and lymphatic system disorders | 1/1 | 1/3 | — |
| LeukopeniaBlood and lymphatic system disorders | 1/1 | 1/3 | — |
| NeutropeniaBlood and lymphatic system disorders | 1/1 | 1/3 | — |
No patients were enrolled into the Vitamin C 100g arm.
| Age, Continuous(years) | Vitamin C 50 g | Vitamin C 75 g | Vitamin C 100 g | Total |
|---|---|---|---|---|
| Median | 73 ± 0 | 76 ± 2.49 | — | 74 ± 2.49 |
| Sex: Female, Male(Participants) | Vitamin C 50 g | Vitamin C 75 g | Vitamin C 100 g | Total |
|---|---|---|---|---|
| Female | 0 | 2 | 0 | 2 |
| Male | 1 | 1 | 0 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Vitamin C 50 g | Vitamin C 75 g | Vitamin C 100 g | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | — | 0 |
| Not Hispanic or Latino | 1 | 3 | — | 4 |
| Unknown or Not Reported | 0 | 0 | — | 0 |
| Race (NIH/OMB)(Participants) | Vitamin C 50 g | Vitamin C 75 g | Vitamin C 100 g | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | — | 0 |
| Asian | 0 | 0 | — | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | — | 0 |
| Black or African American | 0 | 1 | — | 1 |
| White | 1 | 2 | — | 3 |
| More than one race | 0 | 0 | — | 0 |
| Unknown or Not Reported | 0 | 0 | — | 0 |
| Region of Enrollment(participants) | Vitamin C 50 g | Vitamin C 75 g | Vitamin C 100 g | Total |
|---|---|---|---|---|
| United States | 1 | 3 | — | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2018 to primary completion in Nov 2022, 54 months.
Results were first posted in Mar 2024, 1 year 4 months after primary completion.
Of 68 non-industry phase 1/2 interventional studies under Myelodysplastic Syndromes, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 49 and three quarters within 142. This study's 54 months is below that.
Counting every sponsor, half of 109 studies reached it within 78 months; a quarter within 49 and three quarters within 110.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ascorbic Acid