Treatment of FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia with HYML-122 and Cytarabine
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 study is testing a new treatment combining HYML-122 and cytarabine to see if it helps people with FLT3 positive relapsed or refractory acute myeloid leukemia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tarapeutics Science Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT05241093 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy, safety, and pharmacokinetics of HYML-122 in combination with cytarabine for patients with FLT3 positive relapsed or refractory acute myeloid leukemia (AML). It consists of two phases: the first phase establishes the recommended dose of HYML-122, while the second phase treats patients at this dose to further assess its effectiveness and safety. The study is conducted in multiple centers in China and aims to provide a new treatment option for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed FLT3 positive relapsed or refractory AML.
Not a fit: Patients who do not have FLT3 mutations or those with other types of AML may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with FLT3 positive relapsed or refractory AML.
How similar studies have performed: Other studies have shown promising results with similar approaches targeting FLT3 mutations in AML, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Suzhou, Jiangsu
- the First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Depei Wu, MD. PhD — The First Affiliated Hospital of Soochow University
- Study coordinator: Yang Shu, MD. BS.
- Email: shuyang@tarapeutics.com
- Phone: +8613918983465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.