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Relapsed or Refractory Acute Myeloid Leukemia (AML)Phase 2NCT05241093

A Study of HYML-122 and Cytarabine in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

A Phase 2 study testing HYML-122; cytarabine in people with Relapsed or Refractory Acute Myeloid Leukemia (AML), run by Tarapeutics Science Inc. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HYML-122; cytarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
29 Mar 2022to 30 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Yang Shu, MD. BS. contact

+8613918983465

shuyang@tarapeutics.com

China1 site, 1 recruiting

  • the First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Depei Wu, MD. PhD, 0086-0512-67781856, drwudepei@163.com

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Open, Multicenter, Phase II Study to Investigator the Efficacy and Safety of HYML-122 and Cytarabine in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

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.

Read the detailed description

This study will have two phases. Phase 1: the escalation phase is to establish the recommended phase 2 dose (RP2D) of HYML-122 given in combination with cytarabine.

Phase 2: the extension phase study will treat patients with FLT3 positive relapsed or refractory AML with HYML-122 in combination with cytarabine at the RP2D, and further evaluate efficacy and safety.

Being tested
HYML-122; cytarabine
Medical subject headings
Recurrence, Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HYML-122; cytarabineDrug

    HYML-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.

Study groups in NCT05241093
Study groupRoleWhat they receive
HYML-122 plus cytarabineExperimentalThe first three eligible enrolled patients will be treated with initial dosing of HYML-122 400mg bid daily and cytarabine 100mg/m2 intravenously by using "3+3" escalating design to explore RP2D. the Data Monitoring Committee (DMC) will evaluate the safety, efficacy and PK data of the phase 1 subjects and establish the combined regimen recommended dose. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgement of the investigator, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet 1 of the discontinuation criteria, whichever occurs first.
Receives: Drug: HYML-122; cytarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: up to 24 months

  2. composite complete remission (CRc) rate

    CRc rate is defined as the rate of all complete and incomplete remission (CRMRD-+CR+CRp+CRi).

    Measured: up to 24 months.

Secondary outcomes (9)

  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.

    Measured: up to 24 months

  2. 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.

    Measured: up to 24 months

  3. 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.

    Measured: up to 24 months

  4. 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.

    Measured: up to 24 months

  5. Incidence of treatment-emergent adverse events (TEAEs)

    safety and tolerability of investigational product assessed as the number of participants experience adverse events (AEs, CTCAE 5.0) or abnormalities in vital signs, laboratory tests, or electrocardiograms.

    Measured: up to 24 months

  6. Cmax,ss

    Peak plasma concentration at steady state (Cmax,ss)

    Measured: at the end of Cycle 1 (each cycle is 28 days)

  7. Cmin,ss

    minimum observed plasma concentration at steady state (Cmin,ss) of drug in blood plasma

    Measured: at the end of Cycle 1 (each cycle is 28 days)

  8. Cav,ss

    the average steady-state plasma concentration

    Measured: at the end of Cycle 1 (each cycle is 28 days)

  9. AUCss

    the area under the plasma concentration at steady-state

    Measured: at the end of Cycle 1 (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2022
  2. Study start29 Mar 2022
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
level 1: HYML-122 400mg bid (day1-day28) in combination with Cytarabine 100mg/m2 (day1-day7). each cycle is 28 days. level2: HYML-122 600mg bid (day1-day28) in combination with Cytarabine 100mg/m2 (day1-day7). each cycle is 28 days.
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05241093
Sponsor's protocol ID
HYML-122-03
Status last verified
May 2024
First submitted
16 Jan 2022
Last updated
10 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HYML-122; cytarabine in people with Relapsed or Refractory Acute Myeloid Leukemia (AML), run by Tarapeutics Science Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yang Shu, MD. BS. (+8613918983465, shuyang@tarapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05241093.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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