Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05241093
PHASE2

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

Sponsor: Tarapeutics Science Inc.

View on ClinicalTrials.gov

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

DRUG

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