Selinexor and HAAG With/Without HMA in Relapsed/Refractory Acute Leukemia (AML) Patients
NCT05805072 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2023-05-06
Summary
The purpose of this study is to evaluate the efficacy and safety of selinexor and HAAG +/- HMA in relapsed/refractory acute leukemia (AML) patients.
Conditions
- Relapsed/Refractory AML
Interventions
- DRUG
-
Selinexor 60 mg/day, orally on d1,4,8,11
- DRUG
-
Homoharringtonine
Homoharringtonine 1 mg/day intravenously on days 3 to 9
- DRUG
-
cytarabine 10 mg/m2 q12h, intravenously on days 3 to 9
- DRUG
-
Aclacinomycin
aclacinomycin 10 mg/day intravenously on days 3 to 6
- DRUG
-
Granulocyte Colony-Stimulating Factor
granulocyte colony-stimulating factor 50-600 mcg/m2/day intravenously from days 2 to start, this dosage will be adjusted according to the hemogram,
- DRUG
-
Decitabine
Decitabine 20 mg/m2/day intravenously on days 1 to 5.
- DRUG
-
Azacitidine 20 mg/m2/day subcutaneously on days 1 to 7
Sponsors & Collaborators
-
The First Affiliated Hospital of Soochow University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-01
- Primary Completion
- 2024-06-30
- Completion
- 2024-06-30
Countries
- China
Study Locations
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