A Single-arm Open-label Multicenter Clinical Study of Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia
Phase: PHASE3
Conditions: Relapsed or Refractory Acute Myeloid Leukemia
Sponsor: Shanxi Bethune Hospital

A Single-arm Open-label Multicenter Clinical Study 
of Selinexor in Combination With HAD or CAG Rregimens 
in Relapsed or Refractory Acute Myeloid Leukemia 
  
  
Project lead research unit: Shanxi Bethune Hospital 
  
  
  
Version number: V2.0 
Version date: 2022.11.3 
 
Board Status: Approved      
Approval Number: YXLL-2022-134 
Board Name: Ethics Committee of Shanxi Bethune 
Hospital 
Board Affiliation: Shanxi Bethune Hospital 
 
 
 
 
 

Interventions: 
1. Treatment regimen: 
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. 
The two regimens combined with selinexor included: 
(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-elevating drugs were applied throughout the course before 
and after treatment) 
(Bone marrow image indicates hypoproliferation)CAG regimen: 
Granulocyte Colony-Stimulating Factor (G-CSF, 5µg/kg/d, starting 12 
hours before chemotherapy×14 days (d1-d14), aclacinomycin (20mg/d)×4 
days (d1-4), cytarabine (10 mg/ m
 2, subcutaneous injection, once 
every 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 
2 .Subsequent treatment regimen: 
For patients eligible for allogeneic stem cell transplantation, 
stem cell transplantation is performed directly after treatment, and 
two courses (60 mg) of selinexor are maintained once a week and three 
weeks after transplantation; 
Patients who are not eligible for transplantation or who have not 
undergone allogeneic stem cell transplantation should continue with 

two courses of treatment with HAD or CAG regimen, and 
selinexor (60 mg) is used once a week for two weeks. 
Supportive care: 
- Platelet transfusion: Maintain platelet levels> 20 ×10
9/L 
- Red blood cell transfusion: keep hemoglobin> 80×10
9/L 
- Hepatoprotective drugs: routinely used in induction and 
consolidation therapy 
Bone marrow monitoring: 
[Time point]: 10 times in total. These include bone puncture 
every 2 months at initial diagnosis, CR and 
consolidation maintenance period, and 
every 3 months after treatment until 2 years. 
[Monitoring items]: monitoring of bone marrow morphology and 
molecular biology indicators.