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NCT03848754 · ClinicalTrials.gov registry record · Phase 1
Pracinostat and Gemtuzumab Ozogamicin (PraGO) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1 study, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT03848754: Completed Phase 1 study, sponsored by Medical College of Wisconsin.
NCT03848754 is a Phase 1 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03848754, a Phase 1 study, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This is a prospective, single-center phase 1 clinical study aimed at determining the maximum-tolerated dose and safety of the combination of gemtuzumab ozogamicin (GO) and pracinostat (P) in patients with relapsed/refractory acute myeloid leukemia.
Primary Outcome
Maximum-tolerated (MTD) dose of pracinostat in combination with fixed dose GO induction will be determined by the 3+3 design rules. If there are no dose-limiting toxicities (DLTs) in the first three patients, the dose of pracinostat will be escalated to 60mg. Escalation to the next dose level will be done only after the third patient on the previous dose level has been observed for 28 days, and no DLTs were noticed. If there is 1 DLT, an additional 3 patients will be tested at same dose level. I
Interventions
- DRUG Gemtuzumab Ozogamicin 3 mg/m^2
- DRUG Gemtuzumab Ozogamicin 2 mg/m^2
- DRUG Pracinostat - 45 mg
- DRUG Pracinostat - 60 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2019-05-24 |
| Est. Completion | 2021-05-05 |
| Phase | Phase 1 |
What the finished NCT03848754 record still lists
NCT03848754 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 4 interventions - of which Gemtuzumab Ozogamicin 3 mg/m^2 is the first listed.
NCT03848754 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03848754 about?
NCT03848754 is a clinical study titled "Pracinostat and Gemtuzumab Ozogamicin (PraGO) in Patients With Relapsed/Refractory Acute Myeloid Leukemia". This is a prospective, single-center phase 1 clinical study aimed at determining the maximum-tolerated dose and safety of the combination of gemtuzumab ozogamicin (GO) and pracinostat (P) in patients with relapsed/refractory acute myeloid leukemia.
What is the current status of trial NCT03848754?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2019-05-24. Estimated completion is 2021-05-05.
What interventions are being tested in trial NCT03848754?
The interventions under investigation include: Gemtuzumab Ozogamicin 3 mg/m^2 (DRUG), Gemtuzumab Ozogamicin 2 mg/m^2 (DRUG), Pracinostat - 45 mg (DRUG), Pracinostat - 60 mg (DRUG).
Who is sponsoring clinical trial NCT03848754?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03848754's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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