Primary Central Nervous System Lymphoma (PCNSL)Phase 2NCT07523737
Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed/Refractory Primary Central Nervous System Diffuse Large B-Cell Lymphoma
A Phase 2 study testing Pomalidomide, PD-1 / PD-L1 monoclonal antibody and XPO1 inhibitor in people with Primary Central Nervous System Lymphoma (PCNSL) and Diffuse Large B Cell Lymphoma (DLBCL), run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Primary central nervous system diffuse large B-cell lymphoma (PCNSL-DLBCL) is a highly aggressive malignancy accounting for over 80% of primary CNS lymphomas, with an annual incidence of 0.4-0.6 per 100,000 people globally and a rising trend in immunocompetent patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Central Nervous System Lymphoma (PCNSL), Diffuse Large B Cell Lymphoma (DLBCL)
- What is being tested?
- Pomalidomide, PD-1 / PD-L1 monoclonal antibody and XPO1 inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Aug 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed primary central nervous system diffuse large B-cell lymphoma (PCNSL-DLBCL).
- Disease progression or relapse after prior treatment with high-dose methotrexate and/or BTK inhibitors.
- Age between 18 and 75 years.
- ECOG performance status score 0-4.
- Expected overall survival > 3 months.
- No known hypersensitivity to any study drug.
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- White blood cell count ≥ 3×10⁹/L; absolute neutrophil count ≥ 1.0×10⁹/L; platelet count ≥ 50×10⁹/L.
- Serum creatinine ≤ 1.5 mg/dL; creatinine clearance ≥ 50 mL/min.
- ALT and AST ≤ 3× upper limit of normal (ULN); total bilirubin ≤ 2× ULN.
- Signed written informed consent.
Who cannot join
- Presence of another malignant tumor requiring active pharmacological or surgical intervention at present;
- Female patients who are pregnant or breastfeeding;
- Patients (male or female) of reproductive potential who are unwilling to use or fail to use effective contraceptive measures;
- Known hypersensitivity to any study drug or any excipient ingredients of these products;
- Active infection (determined by the investigator);
- History of immunodeficiency, including positive HIV status, other acquired or congenital immunodeficiency disorders, or history of organ transplantation;
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- Documented history of neurological or psychiatric disorders, including epilepsy or dementia;
- Documented history of autoimmune diseases (except Hashimoto's thyroiditis or thyroid dysfunction);
- Any severe comorbidity that, in the investigator's judgment, would compromise patient safety or interfere with the completion of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730
Liang Wang, M.D., +861058266633, wangliangtrhos@126.com
Jia Cong, M.D., +861058268442, congjia21@163.com
About this study
Official title: Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed/Refractory Primary Central Nervous System Diffuse Large B-Cell Lymphoma: A Prospective, Multicenter, Single-Arm, Phase II Clinical Study
Primary central nervous system diffuse large B-cell lymphoma (PCNSL-DLBCL) is a highly aggressive malignancy accounting for over 80% of primary CNS lymphomas, with an annual incidence of 0.4-0.6 per 100,000 people globally and a rising trend in immunocompetent patients. First-line high-dose methotrexate-based chemotherapy causes severe toxicities and nearly 50% of patients relapse within 1-2 years, developing relapsed/refractory (R/R) disease.
Treatment options for R/R PCNSL are scarce, with low response rates, median survival of only 3-6 months, and 5-year survival below 5%. The blood-brain barrier and tumor heterogeneity further worsen outcomes. This prospective, multicenter, single-arm phase II study evaluates the efficacy and safety of pomalidomide, PD-1 inhibitor, and selinexor (PPS) in R/R PCNSL, aiming to provide a new effective treatment.
Read the detailed description
Primary central nervous system diffuse large B-cell lymphoma (PCNSL-DLBCL) is a highly aggressive and uncommon extranodal non-Hodgkin lymphoma that exclusively or predominantly involves the central nervous system. As the predominant subtype of primary central nervous system lymphomas, it accounts for more than 80% of all cases, representing a major clinical challenge in neuro-oncology. Epidemiological studies indicate a global annual incidence of 0.4 to 0.6 per 100,000 individuals, with a gradual increase observed in immunocompetent populations in recent decades. This rising incidence, coupled with its malignant biological behavior, has placed substantial pressure on clinical diagnosis and management.
Currently, high-dose methotrexate (HD-MTX)-based combination chemotherapy remains the standard first-line treatment for PCNSL. Some patients may receive consolidation with local radiotherapy or autologous hematopoietic stem cell transplantation to improve disease control. Nevertheless, this therapeutic strategy has significant limitations. High-dose chemotherapy frequently induces severe adverse events, including myelosuppression, liver and renal toxicity, which are poorly tolerated by elderly patients or those with multiple comorbidities. Despite standardized first-line therapy, approximately 50% of patients experience disease relapse or progression within 1 to 2 years, eventually developing relapsed/refractory (R/R) PCNSL.
For patients with R/R PCNSL, therapeutic options are extremely limited. Existing second-line chemotherapy regimens yield unsatisfactory and inconsistent efficacy, with objective response rates generally below 50%. The median overall survival is only 3 to 6 months, and the 5-year survival rate is less than 5%. In addition to poor survival outcomes, patients often suffer from headache, neurological deficits, cognitive impairment, and other neuropsychiatric symptoms, severely impairing quality of life. Furthermore, the physiological barrier of the blood-brain barrier prevents most conventional chemotherapeutic agents from reaching effective intratumoral concentrations. Meanwhile, the high genetic and phenotypic heterogeneity of tumor cells further compromises treatment efficacy and contributes to drug resistance.
Collectively, the clinical demand for safe and effective treatments in R/R PCNSL remains drastically unmet. Therefore, we designed this prospective, multicenter, single-arm phase II clinical trial to systematically investigate the efficacy and safety of the triplet regimen consisting of pomalidomide, PD-1 monoclonal antibody, and selinexor (PPS) in patients with R/R PCNSL-DLBCL. This study aims to establish a novel and practical therapeutic approach, improve survival and quality of life, and fill the current therapeutic gap for this refractory patient population.
- Being tested
- Pomalidomide, PD-1 / PD-L1 monoclonal antibody, XPO1 inhibitor
- Keywords
- diffuse large b cell lymphoma, primary central nervous system lymphoma, pomalidomide, PD-1 inhibitor, XPO1 inhibitor, 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.
PomalidomideDrug
4 mg on days 1-14, every 3 weeks (q3w), for a total of 6 cycles
PD-1 / PD-L1 monoclonal antibodyDrug
tislelizumab 200 mg on day 1, q3w, for a total of 6 cycles
XPO1 inhibitorDrug
Selinexor: 60 mg on days 1, 8, and 15, q3w, for a total of 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| PPS group | Experimental | All enrolled patients may initiate induction therapy after completing baseline imaging and relevant laboratory examinations:
Pomalidomide: 4 mg on days 1-14, every 3 weeks (q3w), for a total of 6 cycles; Selinexor: 60 mg on days 1, 8, and 15, q3w, for a total of 6 cycles; PD-1 monoclonal antibody: tislelizumab 200 mg on day 1, q3w, for a total of 6 cycles.
During induction therapy, patients who achieve complete response (CR) may discontinue from the study to receive consolidation therapy with autologous hematopoietic stem cell transplantation (AHSCT) or dose-optimized whole-brain radiotherapy (WBRT), at the investigator's discretion or the patient's choice.
For patients not discontinuing for consolidation therapy, maintenance therapy may be administered after 6 cycles of induction therapy: pomalidomide 4 mg every other day (qod) plus selinexor 40-60 mg once weekly (qw), until disease progression or unacceptable toxicity. Receives: Drug: Pomalidomide; Drug: PD-1 / PD-L1 monoclonal antibody; Drug: XPO1 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
best overall response rate (ORR) as of 6 cycles of PPS
Overall response rate means sum of complete response rate and partial response rate
Measured: From the day of initiation of PPS treatment to 3 weeks after 6 cycles of PPS treatment (the length of each cycle is 3 weeks)
Secondary outcomes (4)
Best Complete Response rate (CR) as of 6 cycles of PPS
CR was defined as complete response evaluated using MRI scan
Measured: From the day of initiation of PPS treatment to 3 weeks after 6 cycles of PPS treatment (the length of each cycle is 3 weeks)
Progression free survival (PFS)
PFS was defined from the date of initiation of PPS to the date fo confirmed disease progression or death of any reason
Measured: From the day of initiation of PPS as of 24 months
overall survival (OS)
OS was defined from the date of initiation of PPS to the date fo death
Measured: From the day of initiation of PPS as of 24 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
measured using CTCAE version 5.0
Measured: From the day of initiation of PPS as of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Apr 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Central Nervous System Lymphoma (PCNSL)Studies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe 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
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIANG WANG, Beijing Tongren Hospital
- Investigators
- Liang Wang, M.D., Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523737
- Sponsor's protocol ID
- TRhos-PCNSL-01
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed/Refractory Primary Central Nervous System Diffuse Large B-Cell Lymphoma: A Prospective, Multicenter, Single-Arm, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07523737
- Acronym / sponsor ID
- TRhos-PCNSL-01
- Keywords
- diffuse large b cell lymphoma, primary central nervous system lymphoma, pomalidomide, PD-1 inhibitor, XPO1 inhibitor, selinexor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 13 Apr 2026 (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.
Primary central nervous system diffuse large B-cell lymphoma (PCNSL-DLBCL) is a highly aggressive malignancy accounting for over 80% of primary CNS lymphomas, with an annual incidence of 0.4-0.6 per 100,000 people globally and a rising trend in immunocompetent patients. First-line high-dose methotrexate-based chemotherapy causes severe toxicities and nearly 50% of patients relapse within 1-2 years, developing relapsed/refractory (R/R) disease.
Treatment options for R/R PCNSL are scarce, with low response rates, median survival of only 3-6 months, and 5-year survival below 5%. The blood-brain barrier and tumor heterogeneity further worsen outcomes. This prospective, multicenter, single-arm phase II study evaluates the efficacy and safety of pomalidomide, PD-1 inhibitor, and selinexor (PPS) in R/R PCNSL, aiming to provide a new effective treatment.
Detailed description
Primary central nervous system diffuse large B-cell lymphoma (PCNSL-DLBCL) is a highly aggressive and uncommon extranodal non-Hodgkin lymphoma that exclusively or predominantly involves the central nervous system. As the predominant subtype of primary central nervous system lymphomas, it accounts for more than 80% of all cases, representing a major clinical challenge in neuro-oncology. Epidemiological studies indicate a global annual incidence of 0.4 to 0.6 per 100,000 individuals, with a gradual increase observed in immunocompetent populations in recent decades. This rising incidence, coupled with its malignant biological behavior, has placed substantial pressure on clinical diagnosis and management.
Currently, high-dose methotrexate (HD-MTX)-based combination chemotherapy remains the standard first-line treatment for PCNSL. Some patients may receive consolidation with local radiotherapy or autologous hematopoietic stem cell transplantation to improve disease control. Nevertheless, this therapeutic strategy has significant limitations. High-dose chemotherapy frequently induces severe adverse events, including myelosuppression, liver and renal toxicity, which are poorly tolerated by elderly patients or those with multiple comorbidities. Despite standardized first-line therapy, approximately 50% of patients experience disease relapse or progression within 1 to 2 years, eventually developing relapsed/refractory (R/R) PCNSL.
For patients with R/R PCNSL, therapeutic options are extremely limited. Existing second-line chemotherapy regimens yield unsatisfactory and inconsistent efficacy, with objective response rates generally below 50%. The median overall survival is only 3 to 6 months, and the 5-year survival rate is less than 5%. In addition to poor survival outcomes, patients often suffer from headache, neurological deficits, cognitive impairment, and other neuropsychiatric symptoms, severely impairing quality of life. Furthermore, the physiological barrier of the blood-brain barrier prevents most conventional chemotherapeutic agents from reaching effective intratumoral concentrations. Meanwhile, the high genetic and phenotypic heterogeneity of tumor cells further compromises treatment efficacy and contributes to drug resistance.
Collectively, the clinical demand for safe and effective treatments in R/R PCNSL remains drastically unmet. Therefore, we designed this prospective, multicenter, single-arm phase II clinical trial to systematically investigate the efficacy and safety of the triplet regimen consisting of pomalidomide, PD-1 monoclonal antibody, and selinexor (PPS) in patients with R/R PCNSL-DLBCL. This study aims to establish a novel and practical therapeutic approach, improve survival and quality of life, and fill the current therapeutic gap for this refractory patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PPS group | Experimental | Drug: Pomalidomide, Drug: PD-1 / PD-L1 monoclonal antibody, Drug: XPO1 inhibitorAll enrolled patients may initiate induction therapy after completing baseline imaging and relevant laboratory examinations: Pomalidomide: 4 mg on days 1-14, every 3 weeks (q3w), for a total of 6 cycles; Selinexor: 60 mg on days 1, 8, and 15, q3w, for a total of 6 cycles; PD-1 monoclonal antibody: tislelizumab 200 mg on day 1, q3w, for a total of 6 cycles. During induction therapy, patients who achieve complete response (CR) may discontinue from the study to receive consolidation therapy with autologous hematopoietic stem cell transplantation (AHSCT) or dose-optimized whole-brain radiotherapy (WBRT), at the investigator's discretion or the patient's choice. For patients not discontinuing for consolidation therapy, maintenance therapy may be administered after 6 cycles of induction therapy: pomalidomide 4 mg every other day (qod) plus selinexor 40-60 mg once weekly (qw), until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed primary central nervous system diffuse large B-cell lymphoma (PCNSL-DLBCL).
- Disease progression or relapse after prior treatment with high-dose methotrexate and/or BTK inhibitors.
- Age between 18 and 75 years.
- ECOG performance status score 0-4.
- Expected overall survival > 3 months.
Key exclusion criteria (9 listed)
- Presence of another malignant tumor requiring active pharmacological or surgical intervention at present;
- Female patients who are pregnant or breastfeeding;
- Patients (male or female) of reproductive potential who are unwilling to use or fail to use effective contraceptive measures;
- Known hypersensitivity to any study drug or any excipient ingredients of these products;
- Active infection (determined by the investigator);
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 |
|---|---|---|
| Pomalidomide4 mg on days 1-14, every 3 weeks (q3w), for a total of 6 cycles | Drug | PPS group |
| PD-1 / PD-L1 monoclonal antibodytislelizumab 200 mg on day 1, q3w, for a total of 6 cycles | Drug | PPS group |
| XPO1 inhibitorSelinexor: 60 mg on days 1, 8, and 15, q3w, for a total of 6 cycles | Drug | PPS group |
Primary outcome
best overall response rate (ORR) as of 6 cycles of PPS
Time frame: From the day of initiation of PPS treatment to 3 weeks after 6 cycles of PPS treatment (the length of each cycle is 3 weeks)
Overall response rate means sum of complete response rate and partial response rate
4 secondary outcomes
Best Complete Response rate (CR) as of 6 cycles of PPS
Time frame: From the day of initiation of PPS treatment to 3 weeks after 6 cycles of PPS treatment (the length of each cycle is 3 weeks)
Progression free survival (PFS)
Time frame: From the day of initiation of PPS as of 24 months
overall survival (OS)
Time frame: From the day of initiation of PPS as of 24 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From the day of initiation of PPS as of 24 months
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 15 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Liang Wang, M.D. principal investigator
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pomalidomide, PD-1 / PD-L1 monoclonal antibody and XPO1 inhibitor in people with Primary Central Nervous System Lymphoma (PCNSL) and Diffuse Large B Cell Lymphoma (DLBCL), run by Beijing Tongren Hospital at 1 site 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 10 inclusion and 9 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Liang Wang, M.D. (+861058266633, wangliangtrhos@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
best overall response rate (ORR) as of 6 cycles of PPS (time frame: From the day of initiation of PPS treatment to 3 weeks after 6 cycles of PPS treatment (the length of each cycle is 3 weeks)). 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 15 Apr 2026.