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A Study of HYML-122 and Cytarabine in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
Sponsor: Tarapeutics Science Inc.
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2022-03-29
Completion Date
2026-06-30
Last Updated
2025-04-10
Healthy Volunteers
No
Interventions
HYML-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.
Locations (1)
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China