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

  • STATUS
    Recruiting
  • days left to enroll
    32
  • participants needed
    18
  • sponsor
    Tarapeutics Science Inc.
Updated on 30 May 2022

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.

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.

Details
Condition Relapsed or Refractory Acute Myeloid Leukemia (AML)
Treatment HYML-122; cytarabine
Clinical Study IdentifierNCT05241093
SponsorTarapeutics Science Inc.
Last Modified on30 May 2022

Eligibility

Yes No Not Sure

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
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