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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
Uma Borate
Study ID
NCT06222580
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Acute Myeloid Leukemia With FLT3/ITD Mutation
  • Acute Myeloid Leukemia With KMT2A Rearrangement
  • Acute Myeloid Leukemia With NPM1 Mutation
  • Recurrent Acute Myeloid Leukemia
  • Refractory Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Aspiration and Biopsy — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Gilteritinib — DRUG
    Given PO
  • Revumenib — DRUG
    Given PO
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA

Study Details

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.

Key Dates

Start date
Feb 20, 2024
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (SNDX-5613 and gilteritinib)
    Patients receive SNDX-5613 PO BID and gilteritinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA scan during screening, as well as bone marrow biopsy and aspiration and blood sample collection throughout the study.

Primary Outcome Measure

Incidence of hematologic adverse events (AEs) [ Time Frame: Up to 30 days after completion of study treatment ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
UNC Hospitals, University of North Carolina at Chapel HillChapel HillNorth Carolina24514
Stacie LaPrarie, RN
[email protected]
919-445-4924
Catie Wheeler
[email protected]
919-962-7443
Joshua F Zeidner, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Uma M. Borate, MD, MS
[email protected]
614-293-3316
Uma M. Borate, MD, MS (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Robin Blauser, RN
[email protected]
2156622870
Alexander Perl, MD (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792
Cancer Connect
[email protected]
800-622-8922
Kieran Sahasrabudhe, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UNC Hospitals, University of North Carolina at Chapel Hill· Chapel Hill, NCOhio State University Comprehensive Cancer Center· Columbus, OHUniversity of Pennsylvania· Philadelphia, PAUniversity of Wisconsin Carbone Cancer Center· Madison, WI

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