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NCT06222580 · ClinicalTrials.gov registry record · Phase 1
SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation
A Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by Uma Borate.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 3
- Study locations
NCT06222580 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia that is actively recruiting participants, run by Uma Borate. The registered enrollment target is 30 participants, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (36% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT06222580, a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, is actively recruiting participants, sponsored by Uma Borate.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase I trial tests the safety, side effects, and best dose of SNDX-5613 and gilteritinib for treating patients with acute myeloid leukemia that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) and has a mutation in the FLT3 gene along with either a mutation in the NMP1 gene or a type of mutation called a rearrangement in the MLL gene. SNDX-5613 is in a class of medications called menin inhibitors. It works by blocking the action of mutated MLL and NMP1 proteins that signal cancer cells to multiply. Gilteritinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of mutated FLT3 proteins that signal cancer cells to multiply. Giving SNDX-5613 with gilteritinib may be safe, tolerable and/or effective in treating patients with relapsed/refractory FLT3 mutated acute myeloid leukemia.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Echocardiography Test
- DRUG Revumenib
- PROCEDURE Bone Marrow Aspiration and Biopsy
- DRUG Gilteritinib
Study Locations (3)
North Carolina
- UNC Hospitals, University of North Carolina at Chapel Hill - Chapel Hill
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-02-20 |
| Est. Completion | 2027-02-28 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06222580
The ClinicalTrials.gov registry entry for NCT06222580 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (36% lower). The listed sponsor is Uma Borate, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06222580 reports 3 study locations spanning 3 distinct geographic areas - top geographies include North Carolina, Ohio, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06222580 about?
NCT06222580 is a clinical study titled "SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation". This phase I trial tests the safety, side effects, and best dose of SNDX-5613 and gilteritinib for treating patients with acute myeloid leukemia that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) and has a mutation in the FLT3 gene along wi...
What is the current status of trial NCT06222580?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-02-20. Estimated completion is 2027-02-28.
What conditions does trial NCT06222580 study?
This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With KMT2A Rearrangement, Acute Myeloid Leukemia With NPM1 Mutation.
What interventions are being tested in trial NCT06222580?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Echocardiography Test (PROCEDURE), Revumenib (DRUG), Bone Marrow Aspiration and Biopsy (PROCEDURE), Gilteritinib (DRUG).
Who is sponsoring clinical trial NCT06222580?
This trial is sponsored by Uma Borate, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06222580 being conducted?
This trial has 3 study locations across North Carolina, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.