Acute myeloid leukemia
Conditions
Interventions
Test group:HYML-122 tablets 400mg BID combined with cytarabine (100mg/m2/d)
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, and subject to voluntary participation after full informed consent;And sign the informed consent, 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, the age is >= 18 years old, and the gender is not limited; 3. Subjects with AML (meeting WHO 2016 diagnostic criteria) and refractory or relapsed after 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, and 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 enrolling in the group, and agree to take effective contraceptive measures during and after treatment.
Exclusion criteria
Exclusion criteria: 1. Those who are known or suspected to be allergic to the test drug or any component of cytarabine; 2. Those who have received treatment with cytarabine at or below the prescribed dose of the protocol, and have had intolerable toxicity; 3. History of disease and surgery: diagnosed with acute promyelocytic leukemia or with BCR-ABL positive leukemia (chronic myeloid leukemia blast), and with myeloid sarcoma or extramedullary leukemia; with other malignant tumors (except AML); medical history, excluding: curable carcinoma in situ of the cervix, basal cell carcinoma of the skin, or squamous cell carcinoma, or any other tumor that has been cured (no evidence of disease recurrence within 5 years); Patients who cannot be well controlled by treatment (at rest, systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg); patients with any of the following diseases within 12 months before administration: myocardial infarction, severe or unstable Angina pectoris, coronary artery bypass graft or peripheral artery bypass graft surgery, congestive heart failure, cerebrovascular events (including transient ischemic attack), etc.; with multiple factors affecting oral medication (eg, inability to swallow, chronic diarrhea or Intestinal obstruction, etc.); patients with definite gastrointestinal bleeding tendency, including the following conditions: patients with locally active ulcer lesions and fecal occult blood (>=++); patients with a history of melena and hematemesis within 2 months; investigators Those who believe that gastrointestinal bleeding may occur; have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; the investigator believes that they have other acute serious or chronic medical or psychological diseases and are not suitable to participate in clinical trials Experimenters; patients currently suffering from mental illness, obvious mental disorders or epilepsy; patients with no ability or cognitive ability; patients who underwent major surgical operations within 3 months before screening. 4. Past treatment history: Received other anti-tumor related treatments, such as chemotherapy, within 4 weeks before the start of administration or within 5 times the half-life of the drug (if the half-life of the drug is known, it is calculated as 5 times the half-life, otherwise it is 4 weeks). , immunotherapy, radiotherapy, surgery, etc.; patients who have received live vaccines and/or plan to receive live vaccines after participating in the trial within 4 weeks before the start of administration; have received trial drug treatment within 4 weeks before the start of administration, or Patients who are participating in other clinical trials; patients who have received nitrosourea and mitomycin chemotherapy within 6 weeks before the start of administration; those who have received FLT3 targeted therapy drugs within 6 weeks before the start of administration; First-line regimens, with the exception of sorafenib and midostaurin used as part of induction, consolidation, and/or maintenance therapy; patients previously treated with venetoclax; patients previously treated with allogeneic stem cell transplantation. 5. Laboratory tests: white blood cell count (WBC)>=20 x 10^9/L; abnormal liver function: ALT and/or AST>=2.5 x ULN, serum total bilirubin>=1.5 x ULN; abnormal renal function: serum creatinine >=1.5 x ULN; abnormal coagulation function: fibrinogen <=
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse free survival;Event free survival;Overall survival;Duration of CR remission; | — |
Countries
China
Contacts
Public ContactWu Depei
the First Affiliated Hospital of Soochow University
Outcome results
None listed