Acute myeloid leukemia
Conditions
Interventions
Experimental group:HYML-122 tablet
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Be able to understand the procedures and methods of this clinical trial, with sufficient informed consent, the subjects voluntarily participate and sign the informed consent form, and fully understand and comply with the requirements of the trial protocol and are willing to complete the study as planned; 2. When signing the informed consent, aged >= 18 years, and the gender is not limited; 3. The subject has AML (meeting the WHO 2016 diagnostic criteria) and is refractory or relapsed after receiving first-line AML therapy: (1) Failure to achieve CR/CRi/CRp after at least one cycle of induction therapy; (2) Hematologic recurrence after receiving first-line induction therapy to achieve CR/CRi/CRp; 4. Subjects whose bone marrow or peripheral blood gene test is positive for FLT3 mutation, if the subject has any of the following FLT3 mutation types, can be selected: FLT3-ITD, FLT3-TKD/D835V, FLT3-TKD/D835H; 5. Eastern Cooperative Oncology Group physical condition (ECOG) score <= 2 points (screening period); 6. The expected survival time is more than 3 months; 7. Women of childbearing age must have a negative serum pregnancy test before enrollment, and agree to take effective contraceptive measures during treatment and within 6 months after treatment.
Exclusion criteria
Exclusion criteria: 1. Known or suspected to be allergic to any of the components of this test drug (HYML-122, lactose, hypromellose, low-substituted hypromellose, silicon dioxide, magnesium stearate, titanium dioxide and polyethylene glycol). 2. History of disease and surgery: (1) Diagnosed with acute promyelocytic leukemia or with BCR-ABL positive leukemia (chronic myeloid leukemia blast), and with myeloid sarcoma or extramedullary leukemia; (2) History of other malignant tumors (except AML), excluding: curable cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma, or any other tumors that have been cured (no evidence of disease recurrence within 5 years); (3) Patients with hypertension that cannot be well controlled by drug treatment (at rest, systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg); (4) Patients with any of the following diseases within 12 months before administration: myocardial infarction, severe or unstable angina pectoris, coronary artery bypass grafting or peripheral artery bypass grafting surgery, congestive heart failure, cerebrovascular events (including transient ischemic attack), etc.; (5) There are multiple factors that affect oral drugs (for example, inability to swallow, chronic diarrhea or intestinal obstruction, etc.); (6) Patients with a clear tendency to gastrointestinal bleeding, including the following: patients with locally active ulcer lesions and fecal occult blood (>=++); patients with a history of melena and hematemesis within 2 months; patients with gastrointestinal bleeding in the opinion of the investigators; (7) Have a history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, and a history of organ transplantation; (8) Those who, in the opinion of the investigator, suffer from other acute severe or chronic medical or psychological diseases and are not suitable to participate in clinical trials; (9) Patients currently suffering from mental illness, obvious mental disorders or epilepsy; patients without behavioral or cognitive abilities; (10) Patients who underwent major surgery within the first 3 months of screening. 3. Past treatment history: (1) Patients who have received other anti-tumor related treatments, such as chemotherapy, immunotherapy, radiotherapy, surgery, etc., within 4 weeks before the start of administration or within = 20 x 10^9/L (patients taking hydroxyurea at the same time to stabilize the white blood cell c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse free survival;Event free survival;Overall survival;Duration of complete remission; | — |
Countries
China
Contacts
Public ContactWu Depei
The First Affiliated Hospital of Soochow University
Outcome results
None listed