Acute myeloid leukemia
Conditions
Interventions
Treatment group:Bortezomib plus CLAG
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 and = 60 years old, regardless of gender or race; 2. According to the standards of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2020. v2), patients with AML confirmed by flow cytometry; 3. Comply with the diagnosis of recurrent/refractory AML, including any of the following: 1) No CR was obtained after 2 cycles of standard chemotherapy; 2) The first induction reached CR, but the duration of CR was = 12 months; 3) Recurrent/refractory AML that is ineffective after the first or multiple salvage treatments; 4. Total serum bilirubin = 42 umol/L, serum ALT and AST = 150 umol/L, and serum creatinine = 150 umol/L; 5. Subjects did not receive radiotherapy, chemotherapy, monoclonal antibody treatment or other anti-tumor treatment within 1 week before screening; 6. The estimated survival period is more than 3 months; 7. The ECOG score is 0-2 points.
Exclusion criteria
Exclusion criteria: 1. Recurrent patients after receiving hematopoietic stem cell transplantation; 2. Those who have a history of allergy to bortezomib, cladribine, cytarabine or granulocyte stimulating factor; 3. Subjects with cardiac insufficiency of grade III or IV according to NYHA cardiac function grading standard; 4. Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious cardiac disease within 12 months after admission; 5. ECG showed that QT interval was significantly prolonged, and patients with severe heart disease such as severe arrhythmia in the past; 6. Serious active infection that has not been effectively controlled (except simple urinary tract infection and bacterial pharyngitis); 7. Subjects with autoimmune diseases requiring treatment, immune deficiency or immunosuppressive treatment; 8. Subjects have a history of alcoholism, drug abuse or mental illness; 9. Positive antibody to hepatitis C, AIDS and syphilis; 10. Pregnant and lactating women and subjects with fertility who cannot take effective contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone marrow inspection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Routine blood test; | — |
Countries
China
Contacts
Public ContactXiaoyu Zhu
The First Affiliated Hospital of University of Science and Technology of China
Outcome results
None listed