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
Main Purpose: To observe the efficacy of selinexor in combination with HAD or CAG regimen for relapsed and refractory acute myeloid leukemia :complete remission rate (CR rate), partial remission rate (PR rate), no remission rate (NR rate), complete remission with incomplete hematologic recovery(CRi rate) Secondary Purposes: 1. To observe the recurrence rate of selinexor combined with HAD or CAG regimen for relapsed and refractory acute myeloid leukemia, treatment-related mortality(TRM), Overall Survival (OS), Event-Free Survival (EFS); 2. Safety indicators: to observe adverse events and deaths during treatment with selinexor in combination with HAD or CAG regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Tao Wang
Taiyuan, Shanxi, China
RECRUITINGRemission Rate
complete remission rate(CR rate), partial remission rate (PR rate) , no remission rate (NR rate)
Time frame: max 2 years
Recurrence Rate
After complete remission, (1) naive cells appear in peripheral blood; (2) \>5% of bone marrow naive cells; (3) Extramedullary recurrence(refer to the 2014 NCCN guidelines).
Time frame: max 2 years
Treatment-Related Mortality (TRM)
A death that is considered to be causally linked to a treatment
Time frame: max 2 years
Overall Survival (OS)
Overall survival is a secondary endpoint that will be measured as time from the start of treatment until death from any cause, or the last date the patient was known to be alive
Time frame: max 2 years
Event-Free Survival (EFS)
Event-free survival (EFS) was calculated from the time of informed consent until death, not achieving CR/CRi or relapse after CR/CRi.
Time frame: max 2 years
Safety:Incidence and severity of adverse events
To evaluate the possible adverse events and deaths during treatment with selinexor in combination with HAD or CAG,mainly including liver toxicity, cardiotoxicity, bacterial infection, viral infection, fungal infection.
Time frame: max 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Given per standard of care
Given per standard of care
Given per standard of care