Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia

Sponsor
Shanxi Bethune Hospital
Study ID
NCT05726110
Phase
PHASE3
Status
Recruiting
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Conditions

  • Relapsed or Refractory Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    Given PO
  • Homoharringtonine — DRUG
    Given per standard of care
  • Daunorubicin — DRUG
    Given per standard of care
  • Cytarabine — DRUG
    Given per standard of care
  • Granulocyte Colony-Stimulating Factor — DRUG
    Given per standard of care
  • Aclacinomycin — DRUG
    Given per standard of care

Study Details

This clinical trial studies the efficacy and safety of selinexor combined with HAD or CAG regimen in the treatment of relapsed or refractory acute myeloid leukemia

Key Dates

Start date
Jan 29, 2023
Status verified
Oct 2024
Primary completion
Dec 10, 2024
Completion
Dec 31, 2024

Study Design

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

Arms

  • Experimental: Selinexor、HAD or CAG regimens
    * Selinexor (60 mg) is used twice weekly for two weeks (four times, 240 mg total of selinexor) in combination with HAD or CAG regimens for reinduction therapy in patients with relapsed and refractory AML. * (Bone marrow image indicates active hyperplasia) HAD regimen: homoharringtonine (HHT) (2mg/ m\^2/d)×7days, daunorubicin (DNR, 40mg/ m\^2/d)×3 days, cytarabine (Ara-C,100-200mg/ m\^2/d)×7 days (no leukocyte drugs should be used throughout the treatment process)； * (Bone marrow image indicates hypoproliferation)CAG regimen: Granulocyte Colony-Stimulating Factor (G-CSF, 5ug/kg/d, started 12 hours before chemotherapy×14 days (d1-d14), aclacinomycin (20mg/d)×4 days (d1-4), cytarabine (10 mg/ m\^2, subcutaneous injection, 1 time in 12 hours)×14 days (d1-d14). * G-CSF was discontinued in the CAG regimen when WBC \> 20×10\^9/L, but chemotherapy was not stopped.

Primary Outcome Measure

Remission Rate [ Time Frame: max 2 years ]

Central Contacts