Overview
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.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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.