RecruitingPhase 2NCT05241106

A Study of HYML-122 in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

a Single-arm, Open, Multicenter, Phase II Study to Investigator the Efficacy and Safety of HYML-122 in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Sponsor

Tarapeutics Science Inc.

Enrollment

15 participants

Start Date

Sep 29, 2021

Study Type

INTERVENTIONAL

Conditions

Relapsed or Refractory Acute Myeloid Leukemia (AML)

Summary

this is a single-arm, open, multicenter, phase 2 study to evaluate the efficacy, safety and pharmacokinetics of HYLM-122 monotherapy in Chinese subjects with FLT3 positive relapsed or refractory acute myeloid leukemia.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests the drug HYML-122 alone (without additional chemotherapy) in patients with FLT3-positive acute myeloid leukemia (AML) that has relapsed or stopped responding to prior treatments. It aims to find the right dose and assess early signs of effectiveness. **You may be eligible if...** - You are 18 or older with confirmed AML and a FLT3 gene mutation - Your leukemia has come back or hasn't responded to at least one prior treatment - You are in reasonably good health (ECOG 0–2) with at least 3 months life expectancy - You are willing to use contraception during and after the study **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a history of heavy alcohol use in the past 6 months - You have allergies to HYML-122 ingredients - You have significant abnormalities in labs or medical history per the protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHYML-122

each treatment cycle is comprised of 28-day consecutive dosing of HYML-122. Upon completion of each cycle, patients may continue to receive oral HYML-122 tablets if they are benefit from the treatment and the toxicity is tolerable.