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NCT03433781 · ClinicalTrials.gov registry record · Phase 1
A Phase Ib Study Evaluating the Safety and Tolerability of Vitamin C in Patients With Intermediate or High Risk Myelodysplastic Syndrome With TET2 Mutations
A Phase 1 study of Myelodysplastic Syndromes, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
- 2
- Study locations
NCT03433781: Completed Phase 1 study of Myelodysplastic Syndromes, sponsored by NYU Langone Health.
NCT03433781 is a Phase 1 study of Myelodysplastic Syndromes that has completed, run by NYU Langone Health. The registered enrollment target is 4 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03433781, a Phase 1 study of Myelodysplastic Syndromes, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Vitamin C
Study Locations (2)
Florida
- University of Miami Miller School of Medicine -Sylvester Cancer Center - Miami
New York
- New York University School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2023-05-16 |
| Phase | Phase 1 |
What the finished NCT03433781 record still lists
NCT03433781 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 1 intervention - of which Vitamin C is the first listed.
NCT03433781 reports a single indexed study location in Florida, New York.
Frequently Asked Questions
What is clinical trial NCT03433781 about?
NCT03433781 is a clinical study titled "A Phase Ib Study Evaluating the Safety and Tolerability of Vitamin C in Patients With Intermediate or High Risk Myelodysplastic Syndrome With TET2 Mutations". 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 (internati...
What is the current status of trial NCT03433781?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2018-05-01. Estimated completion is 2023-05-16.
What conditions does trial NCT03433781 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes.
What interventions are being tested in trial NCT03433781?
The interventions under investigation include: Vitamin C (DRUG).
Who is sponsoring clinical trial NCT03433781?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03433781 being conducted?
This trial has 2 study locations across Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03433781's enrollment target sits among peer trials
4 171st of 173 higher than 3 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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