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Tyrosine Kinase Inhibitor

Treatment (SNDX-5613 and gilteritinib) for Acute Myelogenous Leukemia

Phase 1

Recruiting

Led By Uma M Borate, MD, MS

Research Sponsored by Uma Borate

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Age ≥ 18 years at the date of signing the informed consent form (ICF)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of combining two medications, SNDX-5613 and gilteritinib, to treat patients with a specific type of leukemia. The leukemia has either come back

Who is the study for?

This trial is for patients with acute myeloid leukemia that has either returned after treatment or hasn't responded to treatment, and who have specific genetic changes (FLT3 mutation along with an NPM1 mutation or MLL rearrangement).Check my eligibility

What is being tested?

The trial is testing the safety and optimal doses of SNDX-5613 (a menin inhibitor) and gilteritinib (a tyrosine kinase inhibitor), which are drugs designed to block cancer cell growth by targeting certain mutated proteins.See study design

What are the potential side effects?

Potential side effects may include reactions at the drug infusion site, gastrointestinal issues, blood count abnormalities, fatigue, liver function changes, and other symptoms related to organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

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My heart pumps blood well, with an ejection fraction of 50% or higher.

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My leukemia has returned or didn't respond to treatment and has certain genetic features.

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I can swallow pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of hematologic adverse events (AEs)

Incidence of non-hematologic adverse events

Recommended phase 2 dose for drug combination

Secondary outcome measures

Composite Complete Response Rate (CRc)

Duration of response

Event Free Survival

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (SNDX-5613 and gilteritinib)Experimental Treatment4 Interventions

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 bone marrow biopsy and aspiration, and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1700

Gilteritinib

2014

Completed Phase 2

~560

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Uma BorateLead Sponsor

5 Previous Clinical Trials

215 Total Patients Enrolled

Uma M Borate, MD, MSPrincipal InvestigatorOhio State University Comprehensive Cancer Center

1 Previous Clinical Trials

94 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA officially granted approval for the use of SNDX-5613 and gilteritinib as treatments?

"Given that this trial is in Phase 1, the safety assessment for Treatment (SNDX-5613 and gilteritinib) has been rated as 1 due to the limited available data supporting its safety and efficacy."

Answered by AI

Are there any available positions for patients to participate in this clinical trial?

"According to the information available on clinicaltrials.gov, this specific study is no longer accepting candidates for enrollment. The trial was initially posted on March 1st, 2024 and its most recent update occurred on January 16th, 2024. However, it is worth noting that there are currently a total of 1440 other studies actively seeking participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Uma Borate 2024. "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. https://clinicaltrials.gov/ct2/show/NCT06222580.