Actively Recruiting
A Study of HYML-122 in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
Led by Tarapeutics Science Inc. · Updated on 2024-05-14
15
Participants Needed
1
Research Sites
247 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 monotherapy in Chinese subjects with FLT3 positive relapsed or refractory acute myeloid leukemia.
CONDITIONS
Official Title
A Study of HYML-122 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 procedures and voluntarily agree to participate with signed informed consent.
- Male or female at least 18 years old at consent.
- Histologically confirmed AML with either refractory disease after at least 1 induction chemotherapy cycle or relapse after remission.
- Positive for FLT3 mutation in bone marrow or blood following last treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
- Life expectancy of at least 3 months.
- Women of childbearing potential must have a negative pregnancy test at baseline and agree to use effective contraception during treatment and for 6 months after last dose.
You will not qualify if you...
- Known or suspected allergies to HYML-122 or its components including lactose, hydroxypropyl cellulose, silicon dioxide, magnesium stearate, titanium dioxide, polyethylene glycol.
- Medical or surgical history that excludes participation per protocol.
- Previous medical treatments that exclude participation per protocol.
- Abnormal laboratory results disqualifying participation.
- Use of combination treatments or drugs during study that cannot be stopped.
- Alcohol abuse within 6 months before screening defined as heavy or long-term drinking.
- Abortion less than 30 days before screening, pregnant or breastfeeding women, women not using effective contraception, planning pregnancy, or donating eggs/sperm within 6 months after last dose.
- History of drug abuse or addiction.
- Unable to comply with study requirements or deemed 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
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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