Acute myeloid leukemia
Conditions
Interventions
test group:XPO1 inhibitor plus decitabine and BCL-2 inhibitor
New diagnosed with AML and unfit for chemotherapy:XPO1 inhibitor plus decitabine and BCL-2 inhibitor
Sponsors
The first affiliated hospital of Universtiy of Science and Technology of China(Anhui provincial hosptial)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Be aware of and voluntarily sign an informed consent form; 2. At least 18 years old; 3. Patients diagnosed with AML based on the World Health Organization (WHO) 2022 classification, confirmed by bone marrow cell morphology or according to the diagnostic and treatment guidelines for adult acute myeloid leukemia (2018 edition); 4. Queue 1: Diagnosis of relapsed/refractory AML, including any of the following situations: After complete remission, leukemia cells reappear in peripheral blood or primitive cells in bone marrow>5%, or leukemia cell infiltration appears outside the marrow; Primary refractory diseases that have not achieved CR after two courses of induction chemotherapy using standard protocols (including cytarabine and an anthracycline or anthraquinone drug); Patients who undergo consolidation and intensified chemotherapy after CR and experience recurrence within 12 months or recurrence after 12 months but are ineffective with conventional chemotherapy, or who experience two or more relapses; Individuals with persistent extramedullary leukemia; Recurrent cases after hematopoietic stem cell transplantation. 5. Queue 2: Newly diagnosed AML patients who are not suitable for receiving intensified chemotherapy (in accordance with the World Health Organization (WHO) 2022 classification criteria for hematopoietic and lymphocytic tissue tumors, but excluding APL), who are not suitable for receiving intensified chemotherapy: 1) = 75 years old or 2) Age range from 18 to 74 years old, with at least one of the following comorbidities present: The Eastern Cancer Collaborative Group (ECOG) has a physical fitness score of 2, 3, or 4; A history of heart disease with congestive heart failure requires treatment; Ejection score = 50%; Existence of chronic stable angina pectoris; Lung carbon monoxide diffusion capacity (DLCO) = 65%, or first second forced expiratory volume (FEV1) = 65%; Creatinine clearance rate = 30 mL/min to1.5 to = 3.0 × ULN; The doctor determined that it is not suitable to use intensified chemotherapy for other comorbidities. 6. Patients who are suitable for intensified therapy but refuse to accept it; 7. Liver function meets the following standards: Aspartate aminotransferase (AST) = 3.0 × ULN *; Alanine aminotransferase (ALT) = 3.0 × ULN *; Bilirubin = 1.5 × ULN *; For subjects under 75 years old, bilirubin levels can be = 3.0 × ULN; *Unless it is believed to be caused by involvement of leukemia organs. 8. Renal function meets the following criteria: creatinine clearance rate = 30 mL/min (Cockrow Gault formula); 9. Expected survival time = 4 weeks; 10. The subjects should take effective contraceptive measures, and during the screening and research period of female subjects, serum or urine pregnancy tests must be negative.
Exclusion criteria
Exclusion criteria: 1. Those who were diagnosed with tumors other than AML at the same time were excluded from superficial bladder cancer cancer, basal cell carcinoma, squamous cell carcinoma, cervical intraepithelial tumor (CIN), prostatic intraepithelial tumor (PIN), and those who had a history of malignancy; 2. Concurrent autoimmune hemolytic anemia or immune thrombocytopenia; 3. Subjects suffering from AIDS, active hepatitis B or hepatitis C virus infection; 4. Patients with unstable or active cardiovascular diseases or those with a cardiovascular disability status rating greater than level 2 from the New York Heart Association; 5. Known active central involvement of tumors; 6. Newly diagnosed Unfit intensified therapy subjects who have previously received any treatment for AML, except for hydroxyurea; 7. Allergies to any drugs and excipients in the research protocol; 8. The researcher believes that there are other circumstances that are not suitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response (CR) rate;Overall survival (OS);gene expression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Relapse Rate;Disease Free Survival(DFS);Time to Progerss(TTP);MRD change;thromosome change; | — |
Countries
China
Contacts
Public ContactXuhan Zhang
The first affiliated hospital of Universtiy of Science and Technology of China(Anhui provincial hosptial)
Outcome results
None listed