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NOT YET RECRUITING
NCT06062641
PHASE2

Selinexor Combined With R-GDP Regimen for TP53-altered R/R DLBCL

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Selinexor Combined With R-GDP Regimen for TP53-altered Relapsed/Refractory Diffuse Large B-cell Lymphoma: a Single Arm, Single Center, Phase II Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-10-30

Completion Date

2027-09-30

Last Updated

2023-11-07

Healthy Volunteers

No

Interventions

DRUG

SR-GDP

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.

Locations (1)

Ruijin Hospital

Shanghai, Shanhai, China