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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety/tolerability: Incidence of treatment related adverse events (AEs) and dose-limiting toxicities (DLTs)
Secondary outcome measures
Efficacy: Clinical Benefit Rate (CBR)
Efficacy: Overall response rate (ORR)
Efficacy: Overall survival (OS)
+6 moreTrial 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
1,590 Previous Clinical Trials
2,281,462 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My AML with core-binding factor is in its first relapse.I have been diagnosed with acute promyelocytic leukemia.I haven't taken any immune-weakening medications for at least 30 days.I can take pills by mouth and my body can absorb them.I do not have conditions affecting my body's ability to absorb nutrients.I have mostly recovered from side effects of previous treatments, except for low blood counts or hair loss.It has been over 90 days since my transplant.I have HIV and am on protease inhibitor therapy.My brain or spinal cord disease is treated and not causing symptoms.My organs are working well according to my last check-up.I had cancer other than non-melanoma skin cancer in the last 3 years but it was either slow-growing, localized, or fully treated.I agree to use two effective birth control methods during and for 3 months after the study.I have had a solid organ transplant in the past.My MDS is rated as intermediate to very high risk.I have tested positive for Hepatitis C.I can take care of myself and am up and about more than half of my waking hours.I don't have severe symptoms of graft versus host disease, only mild skin issues.I don't have chronic graft versus host disease needing systemic treatment.My leukemia is outside the bone marrow.I am 18 or older and my condition has not improved after at least one treatment.My liver is functioning properly.I am not pregnant or breastfeeding, and I have a negative pregnancy test.My heart pumps well, with an ejection fraction over 45%.My kidney function is normal.I have a diagnosed condition.I have a severe or uncontrolled infection.My CMML is considered intermediate-2 or high risk.I finished my cancer treatment for myeloid neoplasm more than 2 weeks ago or 5 half-lives ago, whichever is longer.I had a stem cell transplant and meet specific conditions.My heart condition is stable.My leukemia has less than 30% myeloblasts in the marrow or white blood cell count under 20,000 without treatment.I had a stem cell transplant over 90 days ago, am not on immunosuppressives, and have no or mild graft vs host disease.
Research Study Groups:
This trial has the following groups:- Group 1: NTX-301
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has NTX-301 been granted clearance from the FDA?
"There is scant evidence regarding the security of NTX-301, so it earned a score of 1."
Answered by AI
Has recruitment for this clinical trial commenced?
"According to clinicaltrials.gov, this medical study is now in the process of enrolling participants. This research initiative was first published on June 1st 2021 and had its most recent update on December 6th 2021."
Answered by AI
What is the estimated sample size for this clinical research?
"Affirmative, clinicaltrials.gov reflects that this research is actively seeking volunteers. It was initially made available on January 6th 2021 and the most recent update occurred on December 6th 2021. This study requires 20 participants from a single medical centre to be recruited."
Answered by AI
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