Actively Recruiting
A Single-arm, Open, Multicenter Phase II Study to Evaluate the Efficacy and Safety of HYML-122 in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia
Led by Tarapeutics Science Inc. · Updated on 2024-05-14
15
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and how the body processes HYML-122 when used alone in Chinese patients with relapsed or refractory acute myeloid leukemia (AML) who have a positive FLT3 mutation. This is a phase 2, open-label, single-arm study conducted at multiple centers to better understand treatment options for this specific group. Participants receive HYML-122 tablets at a dose of 200mg daily for each 28-day treatment cycle. Initially, the first three eligible patients will take 600mg twice daily for 28 days, and a Data Monitoring Committee will review their safety and response data to decide if dose adjustments are needed. Patients who benefit and tolerate the treatment may continue receiving the drug after each cycle. During the study, participants will be closely monitored for treatment response, including remission rates, relapse-free survival, event-free survival, and overall survival up to 24 months. Safety will be evaluated by tracking any adverse events. Blood samples will be collected to study drug levels at the end of the first cycle. The total participation duration and follow-up assessments are planned to capture long-term outcomes and safety data.
CONDITIONS
Brief 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...
- Understand the study procedures and agree to participate voluntarily with signed informed consent
- Male or female aged 18 years or older at consent
- Confirmed diagnosis of acute myeloid leukemia (AML) by WHO 2016 criteria
- AML is refractory to at least one induction chemotherapy cycle or relapsed after remission
- Positive for FLT3 mutation in bone marrow or blood after last treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less at screening
- 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...
- Allergies to HYML-122 or any of its components
- Excluded by medical or surgical history as per protocol
- Prior medical treatments excluded by protocol
- Abnormal lab results excluded by protocol
- Need for combination treatments or drugs during study that cannot be stopped
- Alcohol abuse within 6 months before screening defined by history and quantity
- Abortion less than 30 days before screening, pregnancy, or breastfeeding within one year
- Women not using effective contraception or planning pregnancy/donation within 6 months after last dose
- History of drug abuse
- Unable to complete study due to poor compliance or other reasons or deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation.
Participants receive oral HYML-122 tablets in 28-day consecutive dosing cycles. They may continue treatment if they benefit and tolerate the medication.
Monthly visits for each treatment cycle
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.
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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