Actively Recruiting
A Study of HYML-122 and Cytarabine in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
Led by Tarapeutics Science Inc. · Updated on 2025-04-10
18
Participants Needed
1
Research Sites
222 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of HYML-122 and Cytarabine in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand the study and voluntarily agree with signed informed consent
- Male or female aged 18 years or older
- Confirmed diagnosis of AML by WHO 2016 criteria with relapsed or refractory disease
- Positive for FLT3 mutation in bone marrow or blood after last treatment
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 at screening
- Life expectancy of at least 3 months
- Women of childbearing potential must have a negative pregnancy test at baseline and agree to effective contraception during and 6 months after treatment
You will not qualify if you...
- Known or suspected allergies to HYML-122 or its ingredients
- Medical or surgical history excluding participation as per protocol
- Previous medical treatments excluding participation as per protocol
- Abnormal laboratory results excluding participation as per protocol
- Use of combination treatments or drugs during the study that cannot be stopped
- Alcohol abuse within 6 months prior to screening, including long-term or heavy drinking
- Abortion less than 30 days before screening, pregnant or breastfeeding women, or women not using effective contraception
- History of drug abuse
- Inability to complete the study or judged unsuitable by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
Y
Yang Shu, MD. BS.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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