ClinicalTrials.gov record
Recruiting Phase 1 Interventional

SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation

ClinicalTrials.gov ID: NCT06222580

Public ClinicalTrials.gov record NCT06222580. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Apr 29, 2026, 10:06 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Safety and Efficacy of Dual Menin and FLT3 Inhibition in Patients With Relapsed/Refractory FLT3- Mutated Acute Myeloid Leukemia Containing a Concurrent MLL-Rearrangement or NPM1 Mutation: A Phase I (Ph I) Study of SNDX-5613 + Gilteritinib

Study identification

NCT ID
NCT06222580
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Uma Borate
Other
Enrollment
30 participants

Conditions and interventions

Interventions

  • Biospecimen Collection Procedure
  • Bone Marrow Aspiration and Biopsy Procedure
  • Echocardiography Test Procedure
  • Gilteritinib Drug
  • Multigated Acquisition Scan Procedure
  • Revumenib Drug

Procedure · Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 19, 2024
Primary completion
Jan 30, 2027
Completion
Feb 27, 2027
Last update posted
Mar 12, 2026

2024 – 2027

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
UNC Hospitals, University of North Carolina at Chapel Hill Chapel Hill North Carolina 24514 Recruiting
Ohio State University Comprehensive Cancer Center Columbus Ohio 43210 Recruiting
University of Pennsylvania Philadelphia Pennsylvania 19104 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06222580, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 12, 2026 · Synced Apr 29, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06222580 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →