Selinexor and HAAG With/Without HMA in Relapsed/Refractory Acute Leukemia (AML) Patients

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT05805072
Status
Unknown

Conditions

  • Relapsed/Refractory AML

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    Selinexor 60 mg/day, orally on d1,4,8,11
  • Homoharringtonine — DRUG
    Homoharringtonine 1 mg/day intravenously on days 3 to 9
  • Cytarabine — DRUG
    cytarabine 10 mg/m2 q12h, intravenously on days 3 to 9
  • Aclacinomycin — DRUG
    aclacinomycin 10 mg/day intravenously on days 3 to 6
  • Granulocyte Colony-Stimulating Factor — DRUG
    granulocyte colony-stimulating factor 50-600 mcg/m2/day intravenously from days 2 to start, this dosage will be adjusted according to the hemogram,
  • Decitabine — DRUG
    Decitabine 20 mg/m2/day intravenously on days 1 to 5.
  • Azacitidine — DRUG
    Azacitidine 20 mg/m2/day subcutaneously on days 1 to 7

Study Details

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

Key Dates

Start date
May 1, 2023
Status verified
Mar 2023
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Selinexor+HAAG±HMA

Primary Outcome Measure

Number of Participants With CR/CRi [ Time Frame: End of cycle 1 and 2 (each cycle is 28 days) ]

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