AML
Conditions
Interventions
Case series:HYML-122
Sponsors
The First Affiliated Hospital of Bengbu Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. subjects voluntarily participate in the study and sign the informed consent; 2. Aged 18 to 75 years, male or female; 3. Subject has AML (meeting WHO2016 diagnostic criteria) and meets any of the following conditions: 1) recurrent and/or refractory AML; 2) subjects with remission of AML after induction remission treatment; 3) subjects who were initially diagnosed with AML but did not receive standard chemotherapy regimen; 4. Physical status (ECOG) score of the eastern tumor cooperative group =3 months; 6. Laboratory tests shall meet the following requirements: 1) blood routine: WBC (WBC) =2.8g/dL; P-glutamyl transpeptidase =3.0mmol/L;Blood calcium or greater tendency for 2.0/L; 5) asymptomatic serum amylase abnormality =1.0g/L; Activated partial thromboplastin time (APTT) <=ULN+10s; Prothrombin time (PT) <=ULN+3s; 7. The subject shall be willing to provide valid diagnostic evidence before treatment or accept bone marrow puncture or biopsy for diagnosis, and accept bone marrow puncture or biopsy for efficacy evaluation after treatment; 8. Lactation and fertility: 1) non-lactating women; 2) in addition to postmenopausal (at least 12 months without menstruation) or sterilization, fertile women should be admitted to the study with negative serum pregnancy test and be willing to use the most effective contraceptive measures during the study period and three months after the last administration of the study drug; 3) male subjects, in addition to sterilization, fertile male subjects, are willing to use the most effective contraceptive measures during the trial and during the three months after the last administration of the study drug.
Exclusion criteria
Exclusion criteria: 1. Previous treatment history; 1.1 patients who have received other relevant anti-tumor treatments, such as chemotherapy, immunotherapy, radiotherapy and surgical treatment, within 4 weeks or 140/90mmhg). Note: the blood pressure before the first dose in the screening period (the mean value of blood pressure measured twice at an interval of 24 hours or more) should be controlled within 140/90mmhg. 2.5. doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) =grade 2, or QTcF > 450ms (QTc calculated by Fridericia correction formula QTcF=QT/RR0.33);Patients with a history of advanced torsion ventricular tachycardia or congenital QT prolongation syndrome; 2.7. 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, congestive heart failure, cerebrovascular events (including transient ischemic attack), etc.; 2.8. there are multiple factors affecting oral medications (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction); 2.9. patients with a clear tendency of gastrointestinal bleeding, including: local active ulcer lesion with fecal occult blood (>=++); A history of black stool or hematemesis within 2 months; The researchers believe that gastrointestinal bleeding may occur; 2.10. have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, and have a history of organ transplantation; 2.11. previous abnormal thyroid function could not be maintained within the normal range even under drug treatment; 2.12. infected with human immunodeficiency virus (HIV); 2.13. patients with positive HBV surface antigen (HBsAg) detection and active HBV (HBV nucleic acid quantification >=1.00x103 copies/ml); 2.14. patients who tested positive for anti-hcv and were in the active phase of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT, MTD; | — |
Countries
China
Contacts
Public ContactYanli Yang/Feng Zhang
The First Affiliated Hospital of Bengbu Medical College
Outcome results
None listed