Selinexor in Combination With R-CHOP as the First-line Therapy for TP53-mutated DLBCL Patients (Smart Trial)

Sponsor
Sun Yat-sen University
Study ID
NCT06517511
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Selinexor Oral Tablet [Xpovio] — DRUG
    Selinexor (60mg po D1, 8) is added from the second cycle of R-CHOP regimen.
  • R-CHOP Protocol — DRUG
    Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone

Study Details

This is a prospective, single-arm, multi-center, phase II clinical trial to evaluate the efficacy and safety of selinexor in combination with R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) followed by selinexor maintenance for untreated TP53-mutated diffuse large B-cell lymphoma (DLBCL) patients.

Key Dates

Start date
Aug 1, 2024
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Apr 30, 2028

Study Design

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

Arms

  • Experimental: Selinexor in combination with R-CHOP
    Patients with TP53-mutated diffuse large B-cell lymphoma will receive selinexor in combination with R-CHOP regimen from the second cycle of R-CHOP (3 weeks per cycle). After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with selinexor will be conducted.

Primary Outcome Measure

Complete response rate (CRR) [ Time Frame: Up to 8 cycles (each cycle is 21 days) ]

Central Contacts

Related Studies