SPEL as Introductive Treatment Following Immune-chemotherapy as Consolidated Therapy for R/R DLBCL With p53 and/or c-Myc Expression

Sponsor
The Affiliated Hospital of Qingdao University
Study ID
NCT05498636
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is a phase II multi-center prospective clinical trail which investigates the efficacy and safety of Selinexor combined with prednisone, etoposide and lenalidomide in the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patient with high p53 and/or c-myc expression.

Key Dates

Start date
Oct 1, 2022
Status verified
Aug 2022
Primary completion
Jul 30, 2025
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: SPEL

Primary Outcome Measure

CR rate [ Time Frame: At the end of Cycle 4 (each cycle is 28 days) ]

Central Contacts

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