Overview

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

Status:
Not yet recruiting
Trial end date:
2022-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tarapeutics Science Inc.
Treatments:
Cytarabine
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.