AML
Conditions
Interventions
Treatment group:Selinexor combined with chemotherapy (HMA, HMA-HAG, FLAG)
Sponsors
Zhangzhou Municipal Hospital affiliated to Fujian Medical University
Eligibility
Sex/Gender
All
Age
14 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent form has been signed 2. The subjects must be at least 14 years old and of both sexes 3. Patients diagnosed with relapsed or refractory AML according to the Chinese Guidelines for the Diagnosis and Treatment of Relapsed or Refractory acute myeloid Leukemia (2021 Edition) 4. ECOG performance status 0-2 5. Liver function meets the following criteria :ALT<2.5*ULN, AST<2.5*ULN, total bilirubin <2*ULN 6. Kidney function meets the following criteria : creatinine clearance = 20 mL/min (calculated using the formula of Cockcroft-Gault) 7. No radiotherapy, chemotherapy, targeted therapy, hematopoietic stem cell transplantation or any other treatment was received during the first 4 weeks of enrollment 8. The expected survival period is=3 months 9. subjects should take effective contraceptive measures. During the screening and research of female subjects, the serum or urine pregnancy test must be negative.
Exclusion criteria
Exclusion criteria: 1. There was an active infection that affected the subject's acceptance of the regimen 2. Complicating autoimmune hemolytic anemia or immune thrombocytopenia 3. Subjects had HIV, active hepatitis B or C virus infection 4. Unstable or active cardiovascular system disease meets any of the following criteria:a.Symptomatic myocardial ischemia b. Uncontrolled and clinically significant conduction abnormalities c. Congestive heart failure (CHF) grade =3 as defined by the New York Heart Association (NYHA) d. Acute myocardial infarction (AMI) within 3 months prior to initial medication 5. Allergic to any of the drugs in the study protocol 6. Participants in other clinical trials within 30 days 7. Selinexor has been exposed in the past 8. There are other conditions that the investigator considers inappropriate to participate in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR/CRi; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;Safety and tolerance; | — |
Countries
China
Contacts
Public ContactCongmeng Lin
Zhangzhou Municipal Hospital affiliated to Fujian Medical University
Outcome results
None listed