NTX-301 for Leukemia

Recruiting at 1 trial location

Overseen By Pankit Vachhani

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: University of Alabama at Birmingham

Must not be taking: Protease inhibitors

Disqualifiers: Acute promyelocytic leukemia, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

20 Participants Needed

Trial Summary

What is the purpose of this trial?

NTX-301 is a DNMT1 inhibitor. The drug is an oral drug with preclinical data that has shown preclinical anti-leukemic efficacy. This is the first clinical trial using NTX-301 in patients with myeloid malignancies.

Do I have to stop taking my current medications for the NTX-301 trial?

The trial requires that participants stop taking systemic immunosuppressive medications at least 30 days before starting NTX-301. Additionally, any chemotherapy, radiation, or biologic therapy specific to the myeloid neoplasm must be completed at least 2 weeks or 5 half-lives before starting the trial. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Eligibility Criteria

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.

Inclusion Criteria

Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) ≤3 × ULN.

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.

Exclusion Criteria

Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to:

My AML with core-binding factor is in its first relapse.

I have been diagnosed with acute promyelocytic leukemia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NTX-301, an oral DNMT1 inhibitor, for the treatment of MDS and AML

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Treatment Details

Interventions

• NTX-301

Trial Overview 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.

Participant Groups

Group I: NTX-301 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+