Relapsed/Refractory AML
Conditions
Interventions
Patients with relapsed or refractory acute myeloid leukemia (R/R AML) treated with the regimen of Lisaftoclax, Selinexor, and Chidamide.:Participants will receive lisaftoclax (200 mg on D1, 400 mg on
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 years or older. 2.Participants diagnosed with relapsed/refractory acute myeloid leukemia (R/R-AML) according to the "Chinese Guidelines for the Diagnosis and Treatment of Relapsed/Refractory Acute Myeloid Leukemia (2023 Edition)";Relapsed AML: Defined as one of the following occurring after the patient has achieved complete remission (CR);Reappearance of leukemia cells in peripheral blood;Bone marrow blasts >=5% (excluding other causes such as bone marrow regeneration after consolidation chemotherapy); Refractory AML: Meeting any of the following conditions: Primary patients who have failed to achieve partial remission (PR) or complete remission (CR) after 2 courses of standard regimen treatment;Relapse within 12 months after consolidation/intensification therapy following CR; Relapse after 12 months of CR, but refractory to conventional chemotherapy; Two or more relapses; Persistent extramedullary leukemia that cannot be cleared by treatment. Performance Status 3.ECOG performance status=4 months. 5.WBC Count: White blood cell (WBC) count = 50 mL/min (calculated using the Cockroft-Gault formula). 6.Participants must have recovered to < Grade 2 from the toxicity of prior therapies (according to CTCAE 5.0 criteria), excluding the impact of the primary disease. Excluded from this requirement are: Alopecia, fatigue, pigmentation, stable hypothyroidism under hormone replacement therapy, and post-chemotherapy peripheral neurotoxicity. At least 2 weeks between the end of cytotoxic chemotherapy drug treatment; At least 5 half-lives for non-cytotoxic drugs (if 5 half-lives duration exceeds 4 weeks, the washout period is counted as 4 weeks; if the half-life is unclear, 4 weeks shall prevail);At least 2 weeks interval for anti-tumor traditional Chinese medicine treatment. 7.Capable of understanding and performing visits, treatment, laboratory tests, and other study procedures as planned. 8.Male and female subjects of childbearing potential must use effective contraceptive measures from the date of signing the informed consent form until 6 months after the last dose of the investigational drug. 9.Understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Confirmed diagnosis of Acute Promyelocytic Leukemia (APL). 2.Subjects with central nervous system (CNS) involvement or extramedullary leukemia. 3.White blood cell (WBC) count > 25 × 10^9/L. (Note: For patients meeting other eligibility criteria, the use of WBC-lowering agents to reduce the count to 480 ms in at least 2 of 3 consecutive electrocardiograms (ECGs) during screening; Uncontrolled hypertension (blood pressure remains uncontrolled despite > 1 month of treatment with reasonable and adequate doses of 3 or more antihypertensive drugs [including diuretics], in addition to lifestyle improvement). 7.Patients who may be unable to attend regular visits or follow-ups for any reason. 8.Current or history of other malignancies, except for those who have undergone radical treatment (including curable basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix) with no evidence of recurrence or metastasis within 2 years prior to screening. 9.Underwent major surgery within 4 weeks prior to the first dose. Definition: Major surgery refers to surgery under general anesthesia. Endoscopic examinations for diagnosis and lesion puncture/excision/excisional biopsy are not considered major surgery. Exemption: Placement of vascular access devices is exempt from this exclusion criterion. 10.Active infection requiring systemic treatment, or active HBV or HCV infection, HIV/AIDS, or other severe infectious diseases. Any of the following serological statuses indicate active Hepatitis B or C infection: Hepatitis B surface antigen (HBsAg) positive. Subjects with Hepatitis B core antibody (HBcAb) positive but HBsAg negative may be enrolled if HBV DNA is negative and they are willing to undergo HBV DNA monitoring. Presence of Hepatitis C virus antibodies. Subjects with HCV antibodies but HCV RNA negative may be enrolled. 11.Concurrent participation in other therapeutic clinical trials. 12.Uncontrolled diabetes mellitus, defined as Glycated Hemoglobin (HbA1c) > 9% with significant hyperglycemia. (Note: Diabetic patients with stable blood glucose control may participate in this study but require HbA1c testing every 3 months). 13.Any mental or cognitive disorder that may limit the subject's ability to un
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite Complete Remission Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate;Overall Survival;Event-Free Survival; | — |
Countries
China
Contacts
Public ContactJian Ge
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed