Actively Recruiting
A Single-arm, Open, Multicenter, Phase II Study to Investigate the Efficacy and Safety 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
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of HYML-122 and cytarabine in patients with FLT3 positive relapsed or refractory acute myeloid leukemia (AML). This phase 2, single-arm, open, multicenter study aims to assess the treatment's efficacy, safety, and pharmacokinetics in Chinese adult patients who have undergone prior treatment for AML. The study includes an initial dose escalation phase followed by an extension phase to further evaluate the recommended dose. The study has two phases: Phase 1 is a dose escalation phase to determine the recommended phase 2 dose (RP2D) of HYML-122 combined with cytarabine. HYML-122 is given orally twice daily in doses of either 400 mg or 600 mg or adjusted as per safety and efficacy data. Cytarabine is administered intravenously at 100 mg/m2 once daily for the first seven days of each 28-day treatment cycle. Patients continue treatment in cycles until they no longer benefit, experience unacceptable toxicity, undergo stem cell transplantation, or meet other discontinuation criteria. Participants will undergo regular monitoring of treatment response and safety during up to 24 months of follow-up. Researchers will assess outcomes including overall response rate and composite complete remission rate. Additional evaluations include relapse-free survival, event-free survival, overall survival, and treatment-related side effects. Pharmacokinetic measurements will be taken during the first treatment cycle. Participants must comply with study procedures and attend scheduled visits throughout the treatment period.
CONDITIONS
Brief 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 procedures and voluntarily agree with signed informed consent
- Male or female at least 18 years old at time of consent
- Histologically confirmed acute myeloid leukemia (AML) refractory to at least one induction chemotherapy cycle or relapsed after prior 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...
- Known or suspected allergy to HYML-122 or its components, including lactose, hydroxypropyl cellulose, silicon dioxide, magnesium stearate, titanium dioxide, and polyethylene glycol
- 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 treatments or drugs during the study that cannot be stopped as required by protocol
- Alcohol abuse within 6 months before screening, defined as a long-term history or heavy drinking episodes
- Abortion less than 30 days before screening, pregnancy, lactation, or planning pregnancy or gamete donation within 6 months after last dose
- History of drug abuse or addiction
- Inability to complete the study due to poor compliance or investigator judgment of unsuitability
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, unacceptable toxicity, hematopoietic stem cell transplantation, or discontinuation
Participants receive HYML-122 orally and cytarabine intravenously in 28-day cycles. Treatment continues as long as participants benefit and tolerate it, or until other discontinuation criteria are met.
Daily administration during the first 7 days of each cycle and continuous oral dosing; visit frequency varies based on clinical judgement
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
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here