An Open Label, Single Arm, Single-Center Exploratory Study to Evaluate the Efficacy and Safety of Selinexor and HAAG +/- HMA in Relapsed/Refractory Acute Leukemia (AML) Patients

Selinexor+HAAG+HMA

The purpose of this study is to evaluate the efficacy and safety of selinexor and HAAG +/- HMA in relapsed/refractory acute leukemia (AML) patients.

2023-05-01

2024-06-30

2024-06-30

Not yet recruiting

20

Inclusion Criteria: 1. Men and women aged ≥18 years. 2. Diagnosis of AML (defined according to the 5th of the World Health Organization \[WHO\] 2022 criteria) of any type except for acute promyelocytic leukemia (APL; AML M3)and the following conditions were met: Relapsing or refractory AML 3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. 4. Female patients of child-bearing potential must have a negative serum pregnancy test at screening and agree to use two reliable methods of contraception for six months after their last dose of medication. 5. Patients whose expecting survival time will be more than 3 months. 6. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures. Exclusion Criteria: 1. AML transformed from chronic myeloid leukemia. 2. Patients with APL/AML M3. 3. Presence of CNS leukemia. 4. Uncontrolled infection or other serious disease. 5. Unstable cardiovascular function: Cardiac ejection fraction (EF)\<0.5, or congestive heart failure (CHF) of NYHA Class ≥ 2. 6. Unstable Liver and kidney function:TBLL≥2.0 mg/dl, AST≥3×ULN, Ccr≥50 ml/min, SpO2\<92%. 7. Known human immunodeficiency virus (HIV) infection. 8. Active hepatitis B or hepatitis C infection. 9. Pregnant and lactating women. Patients with other commodities that the investigators considered not suitable for the enrollment.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2023-05-06