Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShanxi Bethune Hospital
About this trial
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
Eligibility criteria
Qualifiers
Age:18-60 years old;
Except for patients with AML-M3 with acute myeloid leukemia；
Meet the diagnostic criteria for refractory AML (2011 Chinese guidelines for the diagnosis and treatment of acute myeloid leukemia (relapsed or refractory)):(1) The standard regimen did not achieve complete remission after 2 courses of induction chemotherapy;(2) Relapse within 6 months after the first complete remission; (3) Patients who relapse after 6 months after the first complete remission, and those who fail to induce chemotherapy after the original program; (4) 2 or more recurrences; (5) Extramedullary leukemia persists；
Meet the diagnostic criteria for recurrent AML (refer to the 2014 NCCN guidelines): after complete remission, (1) naive cells appear in peripheral blood; (2) >5% of bone marrow naive cells; (3) Extramedullary recurrence；
Disqualifiers
Accompanied by cerebral hemorrhage；
Pregnancy；
Have a mental illness or other condition that cannot proceed as planned；
Severe arrhythmia, abnormal ECG (QT>500ms).
Trial design
Treatments tested in this trial
- Selinexor
- Homoharringtonine
- Daunorubicin
- Cytarabine
- Granulocyte Colony-Stimulating Factor
- Aclacinomycin
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Shanxi Bethune Hospital
Lead sponsor
Antengene Corporation
Collaborator
Source ClinicalTrials.gov