Selinexor Combined With R-GemOx as Second-line Treatment in Patients With Diffuse Large B-cell Lymphoma

Sponsor
Chongqing University Cancer Hospital
Study ID
NCT05786989
Phase
PHASE4
Status
Unknown

Conditions

  • Diffuse Large B-Cell Lymphoma, Not Otherwise Specified

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The goal of this interventional study is to evaluate efficiency and safety in prior one-line treated diffuse large B-cell lymphoma. The main questions it aims to answer are: * Complete remission rate * Objective remission rate * Progression-free survival * tolerance Participants will recevied a minimum of 2 and a maximum of 6 cycles of R-GemOx(rituximab 375 mg/m2 IV on day 1 , Gemcitabine 1000 mg/m2, Oxaliplatin 100 mg/m2 IV on day 2) and 60 mg selinexor on days 1, 8, and 15 of each cycle

Key Dates

Start date
Feb 28, 2023
Status verified
Mar 2023
Primary completion
Mar 31, 2024
Completion
Sep 30, 2024

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Patients will receive selinexor PO on days 1, 8, and 15 of a 21 week cycle. R-GemOx will be given at standard dosing every 21 days

Primary Outcome Measure

Complete remission rate [ Time Frame: UP to 2 years ]

Central Contacts

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