RecruitingPhase 2NCT05241093

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

Sponsor

Tarapeutics Science Inc.

Enrollment

18 participants

Start Date

Mar 29, 2022

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 in combination with cytarabine 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 early-phase trial tests HYML-122 combined with the chemotherapy drug cytarabine in patients with a type of leukemia (AML) that has a specific mutation called FLT3, which has come back or stopped responding to prior treatment. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of AML - Your leukemia has the FLT3 mutation - Your disease has relapsed (come back) or is refractory (not responding) to prior therapy - You are in generally good health (ECOG performance status 0–2) - You have a life expectancy of at least 3 months **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a history of heavy alcohol use - You have significant allergies to the study drug ingredients - You have certain medical or lab abnormalities per the study 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; cytarabine

HYML-122 is administered orally consecutive with 400mg bid or 600mg bid or dose adjusted by DMC judgement in each 28-day treatment cycle. cytarabine is administered by intravenous infusion with 100mg/m2 or dose adjusted by DMC judgement once daily on the first to 7th day of each treatment cycle. Upon completion of each 28-day treatment cycle, patients may continue to receive HYML-122 and cytarabine if they are benefit from the treatment and the toxicity is tolerable.