Diffuse Large B Cell LymphomaPhase 2NCT06517511
Selinexor in Combination With R-CHOP as the First-line Therapy for TP53-mutated DLBCL Patients (Smart Trial)
A Phase 2 study testing Selinexor Oral Tablet [Xpovio] and R-CHOP Protocol in people with Diffuse Large B Cell Lymphoma, run by Sun Yat-sen University at 2 sites in China.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Selinexor Oral Tablet [Xpovio] and R-CHOP Protocol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2024to Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Sun yat-sen university cancer center
Guangzhou, Guangdong, 510060
Qingqing Cai, MD. PhD., 0086-20-87342823, caiqq@sysucc.org.cn
Yi Xia, MD. PhD., 0086-20-87342823, xiayi@sysucc.org.cn
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Rong Tao, MD., 86-13651603660, taorong@xinhuamed.com.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Selinexor Oral Tablet [Xpovio], R-CHOP Protocol
- Keywords
- TP53-mutated diffuse large B-cell lymphoma, Selinexor
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selinexor Oral Tablet [Xpovio]Drug
Also called exportin 1 (XPO1) inhibitor
Selinexor (60mg po D1, 8) is added from the second cycle of R-CHOP regimen.
R-CHOP ProtocolDrug
Also called R-CHOP regimen
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
| Study group | Role | What they receive |
|---|---|---|
| Selinexor in combination with R-CHOP | Experimental | 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. Receives: Drug: Selinexor Oral Tablet [Xpovio]; Drug: R-CHOP Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate (CRR)
To investigate the preliminary anti-tumor efficacy
Measured: Up to 8 cycles (each cycle is 21 days)
Secondary outcomes (7)
Disease-free survival (DFS)
To investigate the preliminary anti-tumor efficacy
Measured: 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)
To investigate the preliminary anti-tumor efficacy
Measured: Up to 8 cycles (each cycle is 21 days)
Progression-free survival (PFS)
To investigate the preliminary anti-tumor efficacy
Measured: 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)
To investigate the preliminary anti-tumor efficacy
Measured: 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
To identify the incidence of AE and SAE
Measured: Through study completion, an average of 2 years
Duration of response (DOR)
To investigate the preliminary anti-tumor efficacy
Measured: 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)
To investigate the preliminary anti-tumor efficacy
Measured: From the date of enrollment until the first response, assessed up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Aug 2024
- Primary completionJan 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
- Investigators
- QingQing Cai, MD. PhD., Principal investigator, Sun yat-sen university cancer centeYi Xia, MD. PhD., Principal investigator, Sun yat-sen university cancer centeRong Tao, MD., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517511
- Sponsor's protocol ID
- B2024-333-01
- Status last verified
- Jan 2026
- First submitted
- 14 Jul 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06517511
- Acronym / sponsor ID
- B2024-333-01
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- TP53-mutated diffuse large B-cell lymphoma, Selinexor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Fudan University
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selinexor in combination with R-CHOP | Experimental | Drug: Selinexor Oral Tablet [Xpovio], Drug: R-CHOP ProtocolPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selinexor Oral Tablet [Xpovio]Also: exportin 1 (XPO1) inhibitorSelinexor (60mg po D1, 8) is added from the second cycle of R-CHOP regimen. | Drug | Selinexor in combination with R-CHOP |
| R-CHOP ProtocolAlso: R-CHOP regimenRituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone | Drug | Selinexor in combination with R-CHOP |
Primary outcome
Complete response rate (CRR)
Time frame: Up to 8 cycles (each cycle is 21 days)
To investigate the preliminary anti-tumor efficacy
7 secondary outcomes
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
Objective response rate (ORR)
Time frame: 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
Overall survival (OS)
Time frame: 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
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
Time to response (TTR)
Time frame: From the date of enrollment until the first response, assessed up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
QingQing Cai, MD. PhD. principal investigator
Sun yat-sen university cancer cente
Yi Xia, MD. PhD. principal investigator
Sun yat-sen university cancer cente
Rong Tao, MD. principal investigator
Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selinexor Oral Tablet [Xpovio] and R-CHOP Protocol in people with Diffuse Large B Cell Lymphoma, run by Sun Yat-sen University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact QingQing Cai, MD. PhD. (0086-20-87342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (CRR) (time frame: Up to 8 cycles (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.