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

February 10, 2026 updated by: Qingqing Cai, Sun Yat-sen University

Selinexor in Combination With R-CHOP as the First-line Therapy for TP53-mutated DLBCL Patients: a Single-arm, Multicenter, Phase II Clinical Trial (Smart Trial)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this phase II clinical trial is to evaluate the efficacy and safety of selinexor in combination with R-CHOP for untreated TP53-mutated DLBCL patients.

The induction phase consisted of 8 cycles of selinexor in combination with R-CHOP. After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with selinexor will be conducted.

The primary endpoint is complete response rate.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun yat-sen University Cancer Center
        • Contact:
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects fully understand and voluntarily participate in this study and sign informed consent.
  • Aged ≥18 and ≤80 years, no gender limitation.
  • Histologically confirmed DLBCL with TP53 mutations (allowing transformed or concurrent indolent B-cell non-Hodgkin lymphoma)
  • No prior systemic anti-lymphoma therapy; prior local radiotherapy alone is permitted.
  • There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
  • Expected survival ≥ 3 months.
  • Adequate function of bone marrow, liver, and kidney.

Exclusion Criteria:

  • DLBCL with Hodgkin lymphoma, T-cell lymphoma, or other non-B-cell lymphoma; Richter transformation.
  • DLBCL with central nervous system invasion.
  • The patients had previously received XPO1 inhibitors.
  • The patients have contraindications to any drug in the combined treatment.
  • Patients with chronic active hepatitis B or active hepatitis C. If the background hepatitis B surface antigen (HBsAg) and/or hepatitis B core Antibody (HBcAb) or hepatitis C Virus (HCV) antibody are positive, the further determination for Hepatitis B Virus (HBV) DNA (no more than 2500 copies /mL or 500 IU/mL) and HCV RNA (no more than the lower limit of the assay) can be included. The patients with HBsAg and/or HBcAb positive need to receive anti-HBV drugs.
  • Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
  • Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.
  • Pregnant and lactating women and subjects of childbearing age who do not want to use contraception.
  • Mentally ill persons or persons unable to obtain informed consent.
  • Any condition deemed unsuitable by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Selinexor Oral Tablet [Xpovio]
Selinexor (60mg po D1, 8) is added from the second cycle of R-CHOP regimen.
Other Names:
  • exportin 1 (XPO1) inhibitor
Drug: R-CHOP Protocol
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
Other Names:
  • R-CHOP regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate (CRR)
Time Frame: Up to 8 cycles (each cycle is 21 days)
To investigate the preliminary anti-tumor efficacy
Up to 8 cycles (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS)
Time Frame: From date of the first complete response until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
To investigate the preliminary anti-tumor efficacy
From date of the first complete response until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Objective response rate (ORR)
Time Frame: Up to 8 cycles (each cycle is 21 days)
To investigate the preliminary anti-tumor efficacy
Up to 8 cycles (each cycle is 21 days)
Progression-free survival (PFS)
Time Frame: From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
To investigate the preliminary anti-tumor efficacy
From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival (OS)
Time Frame: From the date of enrollment until the date of death from ant cause, assessed up to 24 months
To investigate the preliminary anti-tumor efficacy
From the date of enrollment until the date of death from ant cause, assessed up to 24 months
Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0
Time Frame: Through study completion, an average of 2 years
To identify the incidence of AE and SAE
Through study completion, an average of 2 years
Duration of response (DOR)
Time Frame: From date of the first CR or PR to the first documented progressive disease or death, whichever occurred earlier, assessed up to 24 months
To investigate the preliminary anti-tumor efficacy
From date of the first CR or PR to the first documented progressive disease or death, whichever occurred earlier, assessed up to 24 months
Time to response (TTR)
Time Frame: From the date of enrollment until the first response, assessed up to 24 weeks
To investigate the preliminary anti-tumor efficacy
From the date of enrollment until the first response, assessed up to 24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The gene mutations such as DDX3X、TET2、PTPN2 and so on are sequenced by whole genome sequencing
Time Frame: Through study completion, an average of 2 years
To explore the correlations between gene mutations and response and prognosis
Through study completion, an average of 2 years
The RNA alterations are sequenced by transcriptome sequencing
Time Frame: Through study completion, an average of 2 years
To explore the correlations between RNA alterations and response and prognosis
Through study completion, an average of 2 years
Genetic classification of DLBCL
Time Frame: Through study completion, an average of 2 years
To explore the correlations between genetic classification of DLBCL and response and prognosis
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Fudan University

Investigators

  • Principal Investigator: QingQing Cai, MD. PhD., Sun yat-sen university cancer cente
  • Principal Investigator: Yi Xia, MD. PhD., Sun yat-sen university cancer cente
  • Principal Investigator: Rong Tao, MD., Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

July 14, 2024

First Submitted That Met QC Criteria

July 18, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2024-333-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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