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NCT03397173 · ClinicalTrials.gov registry record · Phase 2
TET2 Mutations in Myelodysplastic Syndromes and Acute Myeloid Leukemia With Azacitidine + Ascorbic Acid
A Phase 2 study, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT03397173: Completed Phase 2 study, sponsored by Case Comprehensive Cancer Center.
NCT03397173 is a Phase 2 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03397173, a Phase 2 study, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of treatment with azacitidine (an FDA approved drug for the treatment of MDS) and high dose ascorbic acid in patients with TET2 mutations. This approach is intended to enhance the enzymatic activity of TET2 protein, which in term may help to improve counts and symptoms, related to Myelodysplastic Syndromes and Acute Myeloid Leukemia. This combination is specific to individuals who carry this mutation.
Primary Outcome
A binary indicator of overall response, defined as achieving CR, PR, or HI) per 2006 International Working Group (IWG) criteria Responses for MDS patients: Complete Response (CR): Bone marrow: ≤ 5% myeloblasts with normal maturation. Peripheral blood: Hgb ≥ 11 g/dL Platelets ≥ 100 × 109/L Neutrophils ≥ 1.0 × 109/L, Blasts 0% Partial response (PR): All CR criteria if abnormal before treatment except: bone marrow blasts decreased by ≥ 50% over pretreatment but still \> 5% Hematologic Improvement
Interventions
- DRUG Azacitidine
- DRUG Ascorbic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-03-16 |
| Est. Completion | 2021-01-21 |
| Phase | Phase 2 |
What the finished NCT03397173 record still lists
NCT03397173 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Azacitidine is the first listed.
NCT03397173 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03397173 about?
NCT03397173 is a clinical study titled "TET2 Mutations in Myelodysplastic Syndromes and Acute Myeloid Leukemia With Azacitidine + Ascorbic Acid". The purpose of this study is to evaluate the efficacy of treatment with azacitidine (an FDA approved drug for the treatment of MDS) and high dose ascorbic acid in patients with TET2 mutations. This approach is intended to enhance the enzymatic activity of TET2 protein, which in term may help to impr...
What is the current status of trial NCT03397173?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2018-03-16. Estimated completion is 2021-01-21.
What interventions are being tested in trial NCT03397173?
The interventions under investigation include: Azacitidine (DRUG), Ascorbic acid (DRUG).
Who is sponsoring clinical trial NCT03397173?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03397173's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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