A Study of HYML-122 and Cytarabine 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 in combination with cytarabine in Chinese subjects with FLT3 positive relapsed or refractory acute myeloid leukemia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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
Design model
Sequential
Treatments tested in this trial
HYML-122; cytarabine
DrugHYML-122 is administered orally consecutive with 400mg bid or 600mg bid or dose adjusted by DMC judgement in each 28-day treatment cycle. cytarabine is administered by intravenous infusion with 100mg/m2 or dose adjusted by DMC judgement once daily on the first to 7th day of each treatment cycle. Upon completion of each 28-day treatment cycle, patients may continue to receive HYML-122 and cytarabine if they are benefit from the treatment and the toxicity is tolerable.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: HYML-122 plus cytarabineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ORR
overall remission rate, including complete remission without minimum residual disease (CRMRD-), complete remission (CR), complete remission with incomplete hematologic recovery (CRi), complete remission without platelet recovery (CRp), partial remission (PR).
Time frame
up to 24 months2
composite complete remission (CRc) rate
CRc rate is defined as the rate of all complete and incomplete remission (CRMRD-+CR+CRp+CRi).
Time frame
up to 24 months.Secondary outcomes
1
RFS
relapse-free survival, for patients achieving a complete remission, defined as the interval from the date of first documentation of a leukemia free state to date of recurrence, treatment failure, death due to any cause or last contact of the end-of-study follow up, which ever occurs first.
Time frame
up to 24 months2
EFS
event-free survival, EFS is defined as the time from the date of enrollment until the date of documented relapse from CR, CRp or CRi, treatment failure, death from any cause or last contact of the end-of-study follow-up, whichever occurs first.
Time frame
up to 24 months3
OS
overall survival, OS is defined as time from the date of enrollment until the date of death from any cause. For a subject who is not known to have died buy the end-of-study follow-up, OS is censored at the date of last contact.
Time frame
up to 24 months4
DOR-CR
duration of CR remission, DOR-CR is defined as the time from the date of first CR, CRp, CRi until the date of documented relapse.
Time frame
up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov