---
title: A Study of HYML-122 in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
nct_id: NCT05241106
overall_status: RECRUITING
phase: PHASE2
sponsor: Tarapeutics Science Inc.
study_type: INTERVENTIONAL
primary_condition: Relapsed or Refractory Acute Myeloid Leukemia (AML)
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05241106.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05241106"
ct_last_update_post_date: 2024-05-14
last_seen_at: "2026-05-12T06:40:34.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of HYML-122 in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

**Official Title:** 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)

**NCT ID:** [NCT05241106](https://clinicaltrials.gov/study/NCT05241106)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 15
- **Lead Sponsor:** Tarapeutics Science Inc.
- **Conditions:** Relapsed or Refractory Acute Myeloid Leukemia (AML)
- **Start Date:** 2021-09-29
- **Completion Date:** 2026-06-30
- **CT.gov Last Update:** 2024-05-14

## Brief 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **HYML-122 treatment** (EXPERIMENTAL) — HYML-122 tablets, 200mg spec, 28 days for each cycle. The first eligible three enrolled subjects will be administrated with 600mg bid dose regimen for 28 consecutive days ( 1 treatment cycle). The Data Monitoring Committee (DMC) will evaluate the safety, efficacy and PK data of these three subjects and make decision whether the regimen need to be adjusted (increasing/decreasing administration dosing or adjusting dosing frequency).

## Interventions

- **HYML-122** (DRUG) — 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.

## Primary Outcomes

- **ORR** _(time frame: up to 24 months)_ — 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).
- **composite complete remission (CRc) rate** _(time frame: up to 24 months.)_ — CRc rate is defined as the rate of all complete and incomplete remission (CRMRD-+CR+CRp+CRi).

## Secondary Outcomes

- **RFS** _(time frame: up to 24 months)_
- **EFS** _(time frame: up to 24 months)_
- **OS** _(time frame: up to 24 months)_
- **duration of CR remission** _(time frame: up to 24 months)_
- **Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)** _(time frame: up to 24 months)_
- **Cmax,ss** _(time frame: at the end of Cycle 1 (each cycle is 28 days))_
- **Cmin,ss** _(time frame: at the end of Cycle 1 (each cycle is 28 days))_
- **Cav,ss** _(time frame: at the end of Cycle 1 (each cycle is 28 days))_
- **AUCss** _(time frame: at the end of Cycle 1 (each cycle is 28 days))_

## Locations (1)

- the First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the first affiliated hospital of soochow university|suzhou|jiangsu|china` — added _(2026-05-12)_

---

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