About this trial
For relapsed/refractory mantle cell lymphoma patients that previously treated with BTK inhibitors: The first part involves 6 cycles of combined therapy with zuberitamab, selinexor, dexamethasone, and thalidomide. This targeted combination regimen can enhance efficacy while reducing toxic side effects. The second part utilizes Zuberitamab plus selinexor for maintenance consolidation therapy, thereby reducing relapse and prolonging survival.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 18-70, ECOG score 0-2(including ages 18 and 70);
Overall Survival > 6 months;
The diagnosis of mantle cell lymphoma was confirmed by histopathology. 4.At least one measurable lesion;
Disqualifiers
Refusing to take blood samples;
Previous allergies to any of the medications in the regimen;
Pregnant and lactating women;
The researchers believe that major diseases can cause interference in the trial.;
Trial design
Single group
Treatments tested in this trial
ZSDT regimen
DrugThe study is based on the R2 protocol and preclinical and clinical studies of selinexor. For relapsed refractory MCL patients who had received BTK inhibitors: selinexor 60mg once daily on days 1 and 8, zuberitamab 375 mg/m² on day 0, Dexamethasone 20 mg on days 1-3 and 8-9, and thalidomide 200 mg on days 1-21. Each treatment cycle lasted 21 days, with six consecutive cycles. Patients achieving complete remission (CR) or partial response (PR) would receive a year-long maintenance therapy of zuberitamab 375 mg/m² every three months and selinexor 60 mg daily on days 1 and 8. Patients experiencing disease progression (PD) would be excluded from the study.
Treatment groups
Trial outcomes
Primary outcomes
CRR
comple remission rate
Sponsors and contacts
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Zhengzhou University
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: