Status:
RECRUITING
A Study of HYML-122 in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
Lead Sponsor:
Tarapeutics Science Inc.
Conditions:
Relapsed or Refractory Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Fully understand the procedures of the clinical study and participate voluntarily with signed and dated written informed consent form, comply with the requirements of the study protocol.
- Males and/or females at least 18 years old when signing the informed consent form.
- Histologically confirmed AML (defined using WHO criteria 2016) with one of the following:
- Refractory to at least 1 cycle of induction chemotherapy. Relapsed after achieving remission with a prior therapy.
- Subject is positive for FLT3 mutation in bone marrow or blood after completion of the subject's last interventional treatment.
- Eastern cooperative oncology group performance status (ECOG) ≤2 at screening.
- Life expectancy of at least 3 months.
- Women of childbearing potential have a negative pregnancy test at baseline and are willing to employ an effective method of contraception for the entire duration of study treatment and 6 months after the last dose.
Exclusion
- Known or suspected allergies to any of the investigational drug composition (HYML-122, lactose, hydroxypropyl cellulose, hyposubstituted hydroxypropyl cellulose, silicon dioxide, magnesium stearate, titanium dioxide and polyethylene glycol).
- Medical history and surgical history excluded according to the protocol.
- Any previous medical treatment history exclude from the protocol.
- Abnormal laboratory results exclude from the protocol.
- Combination of treatments and/or drugs required during the study period and cannot be discontinued that excluded from the protocol.
- Alcohol abuse within 6 months prior to screening, defined as long-term drinking history, generally more than 5 years, equivalent to alcohol quantity ≥40g/d for men, ≥20g/d for women, or heavy drinking history within 2 weeks, equivalent to alcohol quantity ≥80g/d. alcohol volume (g) conversion formula=alcohol consumption (mL)\*alcohol content (%)\*0.8.
- Abortion less than 30 days prior to screening, pregnant and lactating women (currently breast-feeding or less than one year after delivery although not breast-feeding), women of childbearing potential who are not guaranteed effective contraception during the study, planning pregnancy or donating eggs or sperm within 6 months after the last dose.
- History of drug abuse or drug addicts.
- Subjects may not be able to complete the study duo to poor compliance or other reasons, or unsuitable for the study by the investigator's judgment.
Key Trial Info
Start Date :
September 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05241106
Start Date
September 29 2021
End Date
June 30 2026
Last Update
May 14 2024
Active Locations (1)
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1
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006