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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 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. The trial reports 1 study location across 1 state.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05024552
The ClinicalTrials.gov registry entry for NCT05024552 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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