A Study of HYML-122 in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTarapeutics Science Inc.
About this trial
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 criteria
Qualifiers
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.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HYML-122
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov