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NCT05024552 · ClinicalTrials.gov registry record · Phase 1
Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML
A Phase 1 study of Acute Myeloid Leukemia With FLT3/ITD Mutation, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT05024552: Recruiting Phase 1 study of Acute Myeloid Leukemia With FLT3/ITD Mutation, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT05024552 is a Phase 1 study of Acute Myeloid Leukemia With FLT3/ITD Mutation that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05024552, a Phase 1 study of Acute Myeloid Leukemia With FLT3/ITD Mutation, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
This study combines vyxeos and gilteritinib in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia. Vyxeos and gilteritinib will be given as induction therapy. Those patients entering a complete remission or a complete remission with incomplete blood count recovery will be allowed to proceed to consolidation therapy with vyxeos and gilteritinib. Those patients who do not proceed to an allogeneic stem cell transplant for any reason are able to enter the maintenance phase of this trial using daily gilteritinib
Primary Outcome
Dose escalation will determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Vyxeos plus Gilteritinib. The MTD is the highest dose of the combination therapy that dose not cause unacceptable side effects.
Conditions Studied
Interventions
- DRUG Vyxeos
- DRUG Gilteritinib
Study Locations (1)
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2022-02-25 |
| Est. Completion | 2027-03 |
| Phase | Phase 1 |
What NCT05024552 shows while recruiting
NCT05024552 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Acute Myeloid Leukemia With FLT3/ITD Mutation appearing as the primary indexed condition, and to 2 interventions - of which Vyxeos is the first listed.
NCT05024552 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05024552 about?
NCT05024552 is a clinical study titled "Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML". This study combines vyxeos and gilteritinib in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia. Vyxeos and gilteritinib will be given as induction therapy. Those patients entering a complete remission or a complete remission with incomplete blood count recovery will be allow...
What is the current status of trial NCT05024552?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2022-02-25. Estimated completion is 2027-03.
What conditions does trial NCT05024552 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia With FLT3/ITD Mutation.
What interventions are being tested in trial NCT05024552?
The interventions under investigation include: Vyxeos (DRUG), Gilteritinib (DRUG).
Who is sponsoring clinical trial NCT05024552?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05024552 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05024552's enrollment target sits among peer trials
22 1602nd of 2000 higher than 386 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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