NTX-301 in MDS/AML (NCT04167917) | Clinical Trial Compass
CompletedPhase 1
NTX-301 in MDS/AML
United States22 participantsStarted 2021-01-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before the first study-specific procedure.
✓. 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
✓. Adequate organ function at screening defined as follows \[reasonably minor changes pre-first dose are acceptable if deemed so by the investigator\]:
✓. Patients must have recovered to grade 1 or less from prior toxicity or adverse events (exception of myelosuppression - neutropenia, anemia, thrombocytopenia - and alopecia). Note: Participants with treatment-related toxicities that are unlikely to resolve per the investigator may be enrolled on a case-by-case basis after discussion with the medical monitor
Exclusion criteria
✕. Diagnosis or presence of any of the following:
✕
What they're measuring
1
Safety/tolerability: Incidence of treatment related adverse events (AEs) and dose-limiting toxicities (DLTs)
. Patients who are receiving any other investigational agents.
✕. Pregnant women and women who are breastfeeding are excluded from this study.
✕. Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to:
✕. History of a second malignancy, excluding non-melanoma skin cell cancer, within the last three years. Participants with second malignancies that were indolent, in situ or definitively treated may be enrolled even if less than three years have elapsed since treatment. Consult the monitor if there are any queries.
✕. History of prior solid organ transplant
✕. History of prior sensitivity reaction to any cytidine derivates