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A Study of HYML-122 in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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)

NCT05241106•Tarapeutics Science Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Key Dates

Start Date

September 29, 2021

Primary Completion Date

December 30, 2025

Completion Date

June 30, 2026

Last Updated

May 14, 2024

Enrollment

ESTIMATED participants

Conditions

Relapsed or Refractory Acute Myeloid Leukemia (AML)

Interventions

HYML-122

DRUG

Contacts

Yang Shu, MD. BS.

CONTACT

86-13918983465 shuyang@tarapeutics.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 14, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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