A Study of HYML-122 in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
a Single-arm, Open, Multicenter, Phase II Study to Investigator the Efficacy and Safety of HYML-122 in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
Tarapeutics Science Inc.
15 participants
Sep 29, 2021
INTERVENTIONAL
Conditions
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 myeloid leukemia.
Eligibility
Inclusion Criteria8
- 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 Criteria9
- 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.
Interventions
each treatment cycle is comprised of 28-day consecutive dosing of HYML-122. Upon completion of each cycle, patients may continue to receive oral HYML-122 tablets if they are benefit from the treatment and the toxicity is tolerable.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05241106