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DNMT1 inhibitor

NTX-301 for Leukemia

Phase 1
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men or women ≥18 years with one of the following conditions that is relapsed or refractory to at least one line of therapy: Acute myeloid leukemia as long as with myeloblast percentage in the marrow is ≤ 30% or the peripheral white blood cell count is less than 20,000 cells/μL in the absence of leukoreducing therapy (e.g., hydroxyurea, leukapheresis) MDS classified as intermediate, high, or very high risk by International Prognostic Scoring System-Revised [IPSS-R] criteria CMML classified as intermediate-2 or high risk per CMML-specific prognostic scoring system (CPSS) or clinical/molecular CPSS (CPSS-mol) criteria ECOG performance status of 0, 1, or 2
Able to swallow, retain, and absorb orally administered medication
Must not have
core-binding factor AML in first relapse
acute promyelocytic leukemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug, NTX-301, to see if it can help people with myeloid malignancies (a type of cancer). The drug is taken orally, and has shown promise in earlier studies.

Who is the study for?
Adults (≥18 years) with certain types of blood cancers that have not responded to previous treatments can join this trial. They must be able to take oral medication, have a life expectancy of at least 4 months, and their major organs need to function well. Women who could get pregnant and men must use effective birth control. People with acute promyelocytic leukemia, severe infections, malabsorption issues, recent other cancers or organ transplants cannot participate.
What is being tested?
The trial is testing NTX-301, an oral DNMT1 inhibitor designed to treat myeloid malignancies like Myelomonocytic Leukemia and Acute Myeloid Leukemia. This is the first time it's being used in humans after showing promise in preclinical studies.
What are the potential side effects?
Potential side effects are not listed but may include typical reactions related to cancer medications such as digestive issues, fatigue, liver problems or changes in blood counts due to the drug's mechanism targeting DNA methylation processes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take pills by mouth and my body can absorb them.
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It has been over 90 days since my transplant.
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My MDS is rated as intermediate to very high risk.
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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 don't have severe symptoms of graft versus host disease, only mild skin issues.
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I don't have chronic graft versus host disease needing systemic treatment.
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My CMML is considered intermediate-2 or high risk.
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My leukemia has less than 30% myeloblasts in the marrow or white blood cell count under 20,000 without treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My AML with core-binding factor is in its first relapse.
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I have been diagnosed with acute promyelocytic leukemia.
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I do not have conditions affecting my body's ability to absorb nutrients.
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I have HIV and am on protease inhibitor therapy.
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I have had a solid organ transplant in the past.
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I have tested positive for Hepatitis C.
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My leukemia is outside the bone marrow.
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I have a severe or uncontrolled infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Efficacy: Clinical Benefit Rate (CBR)
Efficacy: Overall response rate (ORR)
Efficacy: Overall survival (OS)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: NTX-301Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,655 Previous Clinical Trials
2,444,138 Total Patients Enrolled

Media Library

NTX-301 (DNMT1 inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04167917 — Phase 1
Myelodysplastic Syndrome Research Study Groups: NTX-301
Myelodysplastic Syndrome Clinical Trial 2023: NTX-301 Highlights & Side Effects. Trial Name: NCT04167917 — Phase 1
NTX-301 (DNMT1 inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04167917 — Phase 1
~9 spots leftby Dec 2027
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