To evaluate the efficacy and safety of selinexor combined with R-GDP regimen in the treatment of patients with TP53-altered relapsed or refractory B-cell lymphoma.
This study is a single-arm, open-label exploratory clinical trial. To evaluate the efficacy and safety of selinexor combined with R-GDP regimen in the treatment of patients with TP53-altered relapsed or refractory B-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Selinexor 40mg/d,po d1,8,15; rituximab 375mg/m2, iv d1; gemcitabine 1g/m2, iv d1,8; cisplatin 25mg/m2, iv d1-3; dexamethasone 40mg,po/iv d1-4 (If patient\>70y, the dosage should be changed to 20mg). Each cycle lasts for 21 days, with a maximum of 6 cycles of combination therapy. For patients who achieved PR or better response at the end of combination therapy, they will start receiving single-agent selinexor 40mg treatment (qw) in cycles of 28 days until disease progression (PD) or unacceptable toxicity occurs.
Ruijin Hospital
Shanghai, Shanhai, China
Objective Response Rate
Objective Response Rate (ORR) : The investigator-assessed best disease status of patients with TP53-altered R/R DLBCL was the rate of Complete Response (CR) or Partial Response (PR)
Time frame: At the end of Cycle 6 (each cycle is 21 days)
progression free survival
Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.
Time frame: Baseline up to data cut-off (up to approximately 2 years)
overall survival
Overall survival was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events
Time frame: Up to 30 days after completion of study treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.