Acute Myeloid Leukemia With FLT3/ITD MutationPhase 1NCT06222580
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 testing Biospecimen Collection, Bone Marrow Aspiration and Biopsy and Gilteritinib in people with Acute Myeloid Leukemia With FLT3/ITD Mutation and Acute Myeloid Leukemia With KMT2A Rearrangement, run by Uma Borate at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With KMT2A Rearrangement, Acute Myeloid Leukemia With NPM1 Mutation
- What is being tested?
- Biospecimen Collection, Bone Marrow Aspiration and Biopsy and Gilteritinib
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Feb 2024to 28 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent must be obtained prior to participation in the study
- Age ≥ 18 years at the date of signing the informed consent form (ICF)
- Morphologically confirmed diagnosis of the following based on 2022 World Health Organization (WHO) classification:
- Relapsed or Refractory Acute Myeloid Leukemia with the following:
- Refractory disease classified as having received 2 cycles of intensive induction or 2 cycles of hypomethylating agent (HMA) + Venetoclax with persistent disease of ≥ 5% blasts in the bone marrow and/or reappearance of peripheral blasts
- FLT-3 mutated disease of the ITD or TKD subtype, AND
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- NPM1 mutation, MLL gene rearrangement and any other mutation that has proven HOXA-MEIS1 overexpression (NUP98, UBTF-TD, MLL-PTD and any others that have supporting literature)
- Patients must be receiving itraconazole, ketoconazole, posaconazole, or voriconazole (strong CYP3A4 inhibitors) for antifungal prophylaxis for at least 24 hours prior to enrollment and while on SNDX-5613 treatment. Patients must not be receiving any other strong CYP3A4 inhibitors/inducers
- Not suitable for immediate myeloablative/intensive chemotherapy based on investigator assessment of age, comorbidities, local guidelines, institutional practice (any or all of these)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 × ULN (except in the setting of isolated Gilbert syndrome)
- Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73m^2 (estimation based on Modification of Diet in Renal Disease (MDRD) formula, by local laboratory)
- Adequate cardiac function defined as ejection fraction (EF) of ≥50% by echocardiogram or multigated acquisition (MUGA) scan
- Patient can communicate with the investigator and has the ability to comply with the requirements of the study procedures
- Participants of childbearing potential must agree to have a negative serum pregnancy test at screening and a negative serum or urine pregnancy test on the first day of study treatment
- Participants capable of impregnating others who are having intercourse with people of childbearing potential must agree to abstain from intercourse or have their partner use 2 forms of contraception from the screening visit until 90 days after the last dose of study treatment. They must also refrain from sperm donation from the screening visit until 90 days following the last dose of study treatment
- Must be able to swallow the study medications
- Any prior treatment-related toxicities resolved to ≤ grade 1 prior to enrollment, with the exception of ≤ grade 2 neuropathy or alopecia
- Patients are not currently receiving the following therapies or have discontinued therapy based on the time periods below:
- Radiation Therapy: At least 60 days from prior total body irradiation (TBI), craniospinal radiation and/or ≥ 50% radiation of the pelvis, or at least 14 days from local palliative radiation therapy (small port)
- Stem Cell Infusion: At least 60 days must have elapsed from hematopoietic stem cell transplant (HSCT) and at least 4 weeks must have elapsed from donor lymphocyte infusion (DLI)
- Immunotherapy: At least 42 days since prior immunotherapy, including tumor vaccines and checkpoint inhibitors, and at least 21 days since receipt of chimeric antigen receptor therapy or other modified T cell therapy
- Antileukemia Therapy***: At least 14 days, or 5 half-lives, whichever is shorter, since the completion of antileukemic therapy (for example, but not limited to, small molecule or cytotoxic/myelosuppressive therapy), with the following exceptions:
- Wah-out can be shorter for patients with rapidly progressing disease as determined by the treating investigator
- Hydroxyurea for cytoreduction can be initiated without restriction related to timing of study entry. Hydroxyurea can be continued concomitantly with SNDX-5613, with medical monitor approval. Patients may continue to receive prophylactic intrathecal chemotherapy at any time at the treating physician's discretion
- Hematopoietic Growth Factors: At least 7 days since the completion of therapy with short-acting hematopoietic growth factors and 14 days with long-acting growth factors
- Biologics (e.g., monoclonal antibody therapy): At least 90 days, or 5 half-lives, whichever is shorter, since the completion of therapy with an antineoplastic biologic agent
- Steroids: At least 7 days since systemic glucocorticoid therapy, unless receiving physiologic dosing (equivalent to ≤10 mg prednisone daily for patients ≥ 18 years or ≤10 mg/m^2 /day for patients
- Prior treatment with gilteritinib is allowed
Who cannot join
- Diagnosis of acute promyelocytic leukemia
- Diagnosis of extra-medullary acute myeloid leukemia (AML) based on WHO 2022 classification or myeloid sarcoma
- Suspected central nervous system (CNS) involvement. Patients with history of cerebrospinal fluid (CSF) involvement must either have documented CSF clearance prior to treatment initiation or be receiving active treatment for CNS involvement
- Participants with prior malignancy, except:
- Participants with history of adequately treated malignancy for which no anticancer systemic therapy (namely chemotherapy, radiotherapy or surgery) is ongoing or required during the course of the study
- Participants who are receiving adjuvant therapy such as hormone therapy are eligible. However, participants who developed therapy related neoplasms are not eligible
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- Previous known allergy/sensitivity to components of gilteritinib or SNDX-5613. Prior treatment with gilteritinib is allowed and does not exclude a patient
- Patient with known human immunodeficiency virus (HIV) or has active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. For patients with evidence of chronic HBV infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Individuals with a history of HCV infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Fridericia's corrected QT interval (QTcF) > 450 msec at time of screening
- Clinically significant ventricular arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
- Uncontrolled intercurrent illness including, but not limited to, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction within 2 months prior to enrollment, New York Heart Association (NYHA) Class III or IV heart failure
- Patients with uncontrolled infection will not be enrolled until infection is treated and under control per the principal investigator or their designee
- Any psychiatric illness that prevents patient from informed consent process
- Pregnant or breastfeeding at the time of enrollment
- Patient has a malabsorption syndrome or other condition that precludes an enteral route of administration
- Patient has history of a cardiovascular, endocrinologic, hepatic, immunologic metabolic, neurologic, psychiatric, pulmonary, renal disease, or any other condition that in the opinion of the investigator would adversely affect his/her participation in this study or interpretation of study results
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States4 sites, 4 recruiting
- Recruiting
UNC Hospitals, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 24514
Stacie LaPrarie, RN, 919-445-4924, stacie_laprarie@med.unc.edu
Catie Wheeler, 919-962-7443, catie_wheeler@med.unc.edu
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Uma M. Borate, MD, MS, 614-293-3316, uma.borate@osumc.edu
Uma M. Borate, MD, MS
- Recruiting
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
Cancer Connect, 800-622-8922, clinicaltrials@cancer.wisc.edu
Kieran Sahasrabudhe, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Robin Blauser, RN, 2156622870, Robin.Blauser@pennmedicine.upenn.edu
Alexander Perl, MD
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the safety of revumenib (SNDX-5613) + gilteritinib.
SECONDARY OBJECTIVES:
- To determine the preliminary efficacy of SNDX- 5613+ Gilteritinib.
EXPLORATORY OBJECTIVES:
- To perform pharmacokinetic and pharmacodynamics assessments of the study drug combination.
OUTLINE: This is a dose-escalation study.
Patients receive SNDX-5613 orally (PO) twice per day (BID) and gilteritinib PO once per day (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiogram (ECHO) or multigated acquisition (MUGA) scan during screening, as well as bone marrow biopsy and aspiration and blood sample collection throughout the study.
After completion of study treatment patients are followed up at 30 days and then every 6 months for up to 2 years.
- 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
- Being tested
- Biospecimen Collection, Bone Marrow Aspiration and Biopsy, Gilteritinib, Revumenib, Echocardiography Test
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Bone Marrow Aspiration and BiopsyProcedure or surgery
Undergo bone marrow aspiration and biopsy
GilteritinibDrug
Also called ASP-2215, ASP2215
Given PO
RevumenibDrug
Also called Menin-Mixed Lineage Leukemia Protein-Protein Interaction Inhibitor SNDX-5613, Menin-MLL Inhibitor SNDX-5613, Menin-MLL Interaction Inhibitor SNDX-5613, SNDX 5613
Given PO
Echocardiography TestProcedure or surgery
Also called EC, Echocardiography, ECHO
Undergo ECHO
Multigated Acquisition ScanProcedure or surgery
Also called Blood pool scan, Equilibrium Radionuclide angiography, Gated blood pool imaging, Gated heart pool scan
Undergo MUGA
| Study group | Role | What they receive |
|---|---|---|
| Treatment (SNDX-5613 and gilteritinib) | Experimental | 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. Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration and Biopsy; Drug: Gilteritinib; Drug: Revumenib; Procedure: Echocardiography Test; Procedure: Multigated Acquisition Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hematologic adverse events (AEs)
Adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. The toxicity data captured will include type, frequency, grade, severity, timing of onset, duration and relationship to study drug. Frequency tables will be used to summarize the AE data, where the number of patients with different types of AE will be tabulated by toxicity grade, counting only the highest grade of a certain type of AE occurred to the same patient. All adverse events regardless of attribution as well as those treatment- related AEs will be summarized.
Measured: Up to 30 days after completion of study treatment
Incidence of non-hematologic adverse events
Adverse events will be graded according to CTCAE v5.0. The toxicity data captured will include type, frequency, grade, severity, timing of onset, duration and relationship to study drug. Frequency tables will be used to summarize the AE data, where the number of patients with different types of AE will be tabulated by toxicity grade, counting only the highest grade of a certain type of AE occurred to the same patient. All adverse events regardless of attribution as well as those treatment- related AEs will be summarized.
Measured: Up to 30 days after completion of study treatment
Recommended phase 2 dose for drug combination
Will be determined based on the maximum tolerated dose in conjunction with pharmacokinetic and pharmacodynamic assessments.
Measured: During cycle 1 (28 days)
Secondary outcomes (6)
Composite Complete Response Rate (CRc)
Will be calculated in the efficacy analysis population and reported along with two-sided 95% exact binomial confidence limits.
Measured: Up to 2 years
Overall Response Rate
Measured: Up to 2 years
Rate of CRc with Measurable Residual Disease Negativity
will be calculated in the efficacy analysis population and reported along with two-sided 95% exact binomial confidence limits.
Measured: Up to 2 years
Duration of response
Will be calculated among patients who achieve a response and estimated using the method of Kaplan-Meier.
Measured: From the date of first response to the earliest documentation of progressive disease, relapsed disease, or death, up to 2 years
Overall Survival
Will be estimated using the method of Kaplan-Meier.
Measured: From date of treatment start to death due to all cause, up to 2 years
Event Free Survival
Will be estimated using the method of Kaplan-Meier.
Measured: From start of treatment to confirmed progressive disease, confirmed morphological relapse from complete remission or complete remission with incomplete hematologic recovery, treatment failure after at least 6 cycles of treatment or death, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start20 Feb 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia With FLT3/ITD MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uma Borate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Uma Borate, Ohio State University Comprehensive Cancer Center
- Investigators
- Uma M Borate, MD, MS, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222580
- Sponsor's protocol ID
- OSU-23199
- Other IDs
- NCI-2024-00036
- Status last verified
- May 2026
- First submitted
- 16 Jan 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06222580
- Acronym / sponsor ID
- OSU-23199
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Uma BorateUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To determine the safety of revumenib (SNDX-5613) + gilteritinib.
SECONDARY OBJECTIVES:
- To determine the preliminary efficacy of SNDX- 5613+ Gilteritinib.
EXPLORATORY OBJECTIVES:
- To perform pharmacokinetic and pharmacodynamics assessments of the study drug combination.
OUTLINE: This is a dose-escalation study.
Patients receive SNDX-5613 orally (PO) twice per day (BID) and gilteritinib PO once per day (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiogram (ECHO) or multigated acquisition (MUGA) scan during screening, as well as bone marrow biopsy and aspiration and blood sample collection throughout the study.
After completion of study treatment patients are followed up at 30 days and then every 6 months for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (SNDX-5613 and gilteritinib) | Experimental | Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspiration and Biopsy, Drug: Gilteritinib, Drug: Revumenib, Procedure: Echocardiography Test, Procedure: Multigated Acquisition ScanPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Signed informed consent must be obtained prior to participation in the study
- Age ≥ 18 years at the date of signing the informed consent form (ICF)
- Morphologically confirmed diagnosis of the following based on 2022 World Health Organization (WHO) classification:
- Patients must be receiving itraconazole, ketoconazole, posaconazole, or voriconazole (strong CYP3A4 inhibitors) for antifungal prophylaxis for at least 24 hours prior to enrollment and while on SNDX-5613 treatment. Patients must not be receiving any other strong CYP3A4 inhibitors/inducers
- Not suitable for immediate myeloablative/intensive chemotherapy based on investigator assessment of age, comorbidities, local guidelines, institutional practice (any or all of these)
Key exclusion criteria (16 listed)
- Diagnosis of acute promyelocytic leukemia
- Diagnosis of extra-medullary acute myeloid leukemia (AML) based on WHO 2022 classification or myeloid sarcoma
- Suspected central nervous system (CNS) involvement. Patients with history of cerebrospinal fluid (CSF) involvement must either have documented CSF clearance prior to treatment initiation or be receiving active treatment for CNS involvement
- Participants with prior malignancy, except:
- Previous known allergy/sensitivity to components of gilteritinib or SNDX-5613. Prior treatment with gilteritinib is allowed and does not exclude a patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (SNDX-5613 and gilteritinib) |
| Bone Marrow Aspiration and BiopsyUndergo bone marrow aspiration and biopsy | Procedure or surgery | Treatment (SNDX-5613 and gilteritinib) |
| GilteritinibAlso: ASP-2215, ASP2215Given PO | Drug | Treatment (SNDX-5613 and gilteritinib) |
| RevumenibAlso: Menin-Mixed Lineage Leukemia Protein-Protein Interaction Inhibitor SNDX-5613, Menin-MLL Inhibitor SNDX-5613, Menin-MLL Interaction Inhibitor SNDX-5613, SNDX 5613Given PO | Drug | Treatment (SNDX-5613 and gilteritinib) |
| Echocardiography TestAlso: EC, Echocardiography, ECHOUndergo ECHO | Procedure or surgery | Treatment (SNDX-5613 and gilteritinib) |
| Multigated Acquisition ScanAlso: Blood pool scan, Equilibrium Radionuclide angiography, Gated blood pool imaging, Gated heart pool scanUndergo MUGA | Procedure or surgery | Treatment (SNDX-5613 and gilteritinib) |
Primary outcome
Incidence of hematologic adverse events (AEs)
Time frame: Up to 30 days after completion of study treatment
Adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. The toxicity data captured will include type, frequency, grade, severity, timing of onset, duration and relationship to study drug. Frequency tables will be used to summarize the AE data, where the number of patients with different types of AE will be tabulated by toxicity grade, counting only the highest grade of a certain type of AE occurred to the same patient. All adverse events regardless of attribution as well as those treatment- related AEs will be summarized.
Incidence of non-hematologic adverse events
Time frame: Up to 30 days after completion of study treatment
Adverse events will be graded according to CTCAE v5.0. The toxicity data captured will include type, frequency, grade, severity, timing of onset, duration and relationship to study drug. Frequency tables will be used to summarize the AE data, where the number of patients with different types of AE will be tabulated by toxicity grade, counting only the highest grade of a certain type of AE occurred to the same patient. All adverse events regardless of attribution as well as those treatment- related AEs will be summarized.
Recommended phase 2 dose for drug combination
Time frame: During cycle 1 (28 days)
Will be determined based on the maximum tolerated dose in conjunction with pharmacokinetic and pharmacodynamic assessments.
6 secondary outcomes
Composite Complete Response Rate (CRc)
Time frame: Up to 2 years
Overall Response Rate
Time frame: Up to 2 years
Rate of CRc with Measurable Residual Disease Negativity
Time frame: Up to 2 years
Duration of response
Time frame: From the date of first response to the earliest documentation of progressive disease, relapsed disease, or death, up to 2 years
Overall Survival
Time frame: From date of treatment start to death due to all cause, up to 2 years
Event Free Survival
Time frame: From start of treatment to confirmed progressive disease, confirmed morphological relapse from complete remission or complete remission with incomplete hematologic recovery, treatment failure after at least 6 cycles of treatment or death, up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Ohio State University Comprehensive Cancer Center contact
Uma M Borate, MD, MS principal investigator
Ohio State University Comprehensive Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biospecimen Collection, Bone Marrow Aspiration and Biopsy and Gilteritinib in people with Acute Myeloid Leukemia With FLT3/ITD Mutation and Acute Myeloid Leukemia With KMT2A Rearrangement, run by Uma Borate at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hematologic adverse events (AEs) (time frame: Up to 30 days after completion of study treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.