LymphomasPhase 2NCT07002099
Selinexor, High-dose Methotrexate, and Rituximab Combined With Radiotherapy for Newly Diagnosed, Transplant-ineligible Patients With Central Nervous System Lymphoma: An Open-label, Single-arm, Multicenter Phase II Study
A Phase 2 study testing Selinexor + High-dose Methotrexate + Rituximab + WBRT in people with Lymphomas, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This phase II clinical trial is designed to evaluate a novel combination treatment for patients with newly diagnosed central nervous system lymphoma (CNSL) who are not candidates for stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphomas
- What is being tested?
- Selinexor + High-dose Methotrexate + Rituximab + WBRT
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, male or female.
- Histologically confirmed primary CNS lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL) with CNS-only involvement.
- Ineligible for autologous stem cell transplantation based on clinical assessment or patient refusal.
- At least one measurable brain lesion ≥1 cm in diameter, or positive cerebrospinal fluid (CSF) cytology/flow cytometry for patients with leptomeningeal disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
- Adequate organ function, including:
Show all 16Show fewer
- Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L
- Platelets ≥ 75 × 10⁹/L
- Hemoglobin ≥ 80 g/L
- Total bilirubin ≤ 1.5 × ULN (or ≤ 3 × ULN if liver involvement)
- ALT and AST ≤ 2.5 × ULN (or ≤ 5 × ULN if liver involvement)
- Creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula)
- INR ≤ 1.5 × ULN; APTT within 10 seconds of normal
- Estimated life expectancy of ≥ 3 months.
- Negative serum pregnancy test for women of childbearing potential.
- Ability to understand and willingness to sign a written informed consent form.
Who cannot join
- CNS involvement limited to intraocular lymphoma only.
- Prior systemic therapy for CNS lymphoma.
- SCNSL with active systemic (non-CNS) disease involvement.
- Uncontrolled intracranial hypertension.
- Clinically significant or unstable cardiovascular disease, including:
- Myocardial infarction within 6 months
Show all 17Show fewer
- Unstable angina within 3 months
- Uncontrolled arrhythmias (e.g., ventricular tachycardia/fibrillation)
- Congestive heart failure NYHA class ≥ III
- LVEF < 50% by echocardiography
- Other severe uncontrolled medical conditions, including active infections requiring systemic therapy.
- Known active hepatitis B (HBV), hepatitis C (HCV), or HIV infection.
- Active gastrointestinal dysfunction that interferes with the ability to swallow or absorb oral medication.
- Prior treatment with selective inhibitor of nuclear export (SINE) compounds, including selinexor.
- Concurrent malignancy, except for adequately treated basal/squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the cervix, prostate, or breast.
- Pregnant or breastfeeding women, or subjects unwilling to use medically accepted effective contraception during the study and for 6 months after the last dose.
- Any condition which, in the investigator's judgment, would make the patient unsuitable for study participation.
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
The Second Affiliated Hospital of Soochow University
Suzhou, 215000
Bingzong Li, 86-512-67784069, lbzwz0907@hotmail.com
Yuchen Zhang, +8615250035366, 1520287376@qq.com
About this study
This phase II clinical trial is designed to evaluate a novel combination treatment for patients with newly diagnosed central nervous system lymphoma (CNSL) who are not candidates for stem cell transplantation. The study will assess the safety and effectiveness of combining selinexor (an oral selective nuclear export inhibitor) with high-dose methotrexate and rituximab chemotherapy, followed by low-dose whole-brain radiotherapy (WBRT). Selinexor has shown promise in enhancing the effects of chemotherapy and radiation in blood cancers.
Patients enrolled in this open-label, single-arm, multicenter study will receive up to six 21-day treatment cycles. Those who respond well will undergo reduced-dose WBRT and continue selinexor as maintenance therapy. The study will measure how many patients respond to the treatment (overall response rate), how long the response lasts (progression-free survival), overall survival, and safety.
This research aims to provide a less toxic and more effective option for treating CNSL in patients who are older or medically unfit for transplantation.
Read the detailed description
This is a prospective, investigator-initiated, open-label, single-arm, multicenter phase II clinical trial designed to evaluate the efficacy and safety of a combination regimen consisting of selinexor, high-dose methotrexate (HD-MTX), and rituximab, followed by low-dose whole-brain radiotherapy (WBRT), in patients with newly diagnosed primary or secondary central nervous system lymphoma (PCNSL or SCNSL) who are not eligible for autologous stem cell transplantation (ASCT).
Selinexor is a first-in-class, selective inhibitor of nuclear export (SINE) targeting XPO1/CRM1. By blocking nuclear export, selinexor restores nuclear localization and activity of multiple tumor suppressor proteins and growth regulatory factors. Preclinical studies suggest that selinexor may enhance the antitumor activity of chemotherapy and radiotherapy, particularly in hematologic malignancies. Its role in CNSL is supported by its ability to cross the blood-brain barrier and sensitize lymphoma cells to treatment.
Eligible patients will receive six 21-day cycles of combination therapy: rituximab 375 mg/m² IV on day 0, HD-MTX 3.5 g/m² IV over 4 hours on day 1, and selinexor 80 mg orally once weekly (days 1, 8, and 15). Tumor response will be assessed every three cycles. Patients achieving at least partial response (PR) will proceed to consolidative low-dose WBRT (23.4 Gy in 13 fractions), followed by maintenance selinexor (80 mg orally once weekly) until disease progression or unacceptable toxicity.
The primary endpoint is the overall response rate (ORR) based on the Lugano 2014 criteria. Secondary endpoints include complete response rate (CRR), progression-free survival (PFS), overall survival (OS), and safety/tolerability assessed by CTCAE v5.0.
A total of 26 patients will be enrolled. This study aims to provide an effective treatment option for transplant-ineligible CNSL patients and to explore the potential synergistic effects of selinexor with chemotherapy and radiotherapy.
- Conditions
- Lymphomas
- Being tested
- Selinexor + High-dose Methotrexate + Rituximab + WBRT
- Keywords
- Selinexor, central nervous system lymphoma, WBRT
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selinexor + High-dose Methotrexate + Rituximab + WBRTDrug
Rituximab 375 mg/m² intravenously on Day 0 of each 21-day cycle
High-dose Methotrexate (HD-MTX) 3.5 g/m² intravenously over 4 hours on Day 1 of each cycle
Selinexor 80 mg orally once weekly (on Days 1, 8, and 15) during each cycle
Treatment is administered every 21 days for up to 6 cycles. Tumor response will be evaluated every 3 cycles.
Patients who achieve a partial response (PR) or better will undergo consolidative low-dose whole-brain radiotherapy (WBRT) at 23.4 Gy in 13 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Participants in this single-arm study will receive combination therapy as follows:
Rituximab 375 mg/m² intravenously on Day 0 of each 21-day cycle High-dose Methotrexate (HD-MTX) 3.5 g/m² intravenously over 4 hours on Day 1 of each cycle Selinexor 80 mg orally once weekly (on Days 1, 8, and 15) during each cycle Treatment is administered every 21 days for up to 6 cycles. Tumor response will be evaluated every 3 cycles.
Patients who achieve a partial response (PR) or better will undergo consolidative low-dose whole-brain radiotherapy (WBRT) at 23.4 Gy in 13 fractions.
After radiotherapy, patients who maintain a response will continue with maintenance selinexor 80 mg orally once weekly until disease progression, unacceptable toxicity, or withdrawal.
This arm is designed to assess the synergistic effect of selinexor when combined with standard CNSL chemotherapy and radiotherapy in patients who are not eligible for stem cell transplantation. Receives: Drug: Selinexor + High-dose Methotrexate + Rituximab + WBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
The proportion of participants who achieve a complete response (CR) or partial response (PR) as assessed by investigators according to the 2014 Lugano classification for lymphoma response evaluation.
Measured: 2 years
Secondary outcomes (1)
PFS
Time from enrollment to disease progression or death from any cause, whichever occurs first.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for LymphomasStudies of the same condition, open and under way.
- 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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bingzong Li, Principal investigator, Second Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002099
- Sponsor's protocol ID
- LK2024097
- Status last verified
- May 2025
- First submitted
- 23 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Houillier C, Soussain C, Ghesquieres H, Soubeyran P, Chinot O, Taillandier L, Lamy T, Choquet S, Ahle G, Damaj G, Agape P, Molucon-Chabrot C, Amiel A, Delwail V, Fabbro M, Jardin F, Chauchet A, Moles-Moreau MP, Morschhauser F, Casasnovas O, Gressin R, Fornecker LM, Abraham J, Marolleau JP, Tempescul A, Campello C, Colin P, Tamburini J, Laribi K, Serrier C, Haioun C, Chebrek S, Schmitt A, Blonski M, Houot R, Boyle E, Bay JO, Oberic L, Tabouret E, Waultier A, Martin-Duverneuil N, Touitou V, Cassoux N, Kas A, Mokhtari K, Charlotte F, Alentorn A, Feuvret L, Le Garff-Tavernier M, Costopoulos M, Mathon B, Peyre M, Delgadillo D, Douzane H, Genet D, Aidaoui B, Hoang-Xuan K, Gyan E. Management and outcome of primary CNS lymphoma in the modern era: An LOC network study. Neurology. 2020 Mar 10;94(10):e1027-e1039. doi: 10.1212/WNL.0000000000008900. Epub 2020 Jan 6.
PubMed 31907289Walker JS, Garzon R, Lapalombella R. Selinexor for advanced hematologic malignancies. Leuk Lymphoma. 2020 Oct;61(10):2335-2350. doi: 10.1080/10428194.2020.1775210. Epub 2020 Jun 14.
PubMed 32536290Neupane K, Wahab A, Masood A, Faraz T, Bahram S, Ehsan H, Hannan A, Anwer F. Profile and Management of Toxicity of Selinexor and Belantamab Mafodotin for the Treatment of Triple Class Refractory Multiple Myeloma. J Blood Med. 2021 Jul 1;12:529-550. doi: 10.2147/JBM.S317966. eCollection 2021.
PubMed 34234609Lurain K, Uldrick TS, Ramaswami R, Polizzotto MN, Goncalves PH, Widell A, Steinberg SM, Jaffe ES, Pittaluga S, Wang HW, Yuan CM, Tamula MA, Martin S, Wolters PL, George J, Little RF, Yarchoan R. Treatment of HIV-associated primary CNS lymphoma with antiretroviral therapy, rituximab, and high-dose methotrexate. Blood. 2020 Nov 5;136(19):2229-2232. doi: 10.1182/blood.2020006048. No abstract available.
PubMed 32609814Gandhi MK, Hoang T, Law SC, Brosda S, O'Rourke K, Tobin JWD, Vari F, Murigneux V, Fink L, Gunawardana J, Gould C, Oey H, Bednarska K, Delecluse S, Trappe RU, Merida de Long L, Sabdia MB, Bhagat G, Hapgood G, Blyth E, Clancy L, Wight J, Hawkes E, Rimsza LM, Maguire A, Bojarczuk K, Chapuy B, Keane C. EBV-associated primary CNS lymphoma occurring after immunosuppression is a distinct immunobiological entity. Blood. 2021 Mar 18;137(11):1468-1477. doi: 10.1182/blood.2020008520.
PubMed 33202420Ostrom QT, Cioffi G, Waite K, Kruchko C, Barnholtz-Sloan JS. CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2014-2018. Neuro Oncol. 2021 Oct 5;23(12 Suppl 2):iii1-iii105. doi: 10.1093/neuonc/noab200.
PubMed 34608945
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selinexor, High-dose Methotrexate, and Rituximab Combined With Radiotherapy for Newly Diagnosed, Transplant-ineligible Patients With Central Nervous System Lymphoma: An Open-label, Single-arm, Multicenter Phase II Study
- ClinicalTrials.gov ID
- NCT07002099
- Acronym / sponsor ID
- LK2024097
- Conditions
- Lymphomas
- Keywords
- Selinexor, central nervous system lymphoma, WBRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Jun 2025 (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 phase II clinical trial is designed to evaluate a novel combination treatment for patients with newly diagnosed central nervous system lymphoma (CNSL) who are not candidates for stem cell transplantation. The study will assess the safety and effectiveness of combining selinexor (an oral selective nuclear export inhibitor) with high-dose methotrexate and rituximab chemotherapy, followed by low-dose whole-brain radiotherapy (WBRT). Selinexor has shown promise in enhancing the effects of chemotherapy and radiation in blood cancers.
Patients enrolled in this open-label, single-arm, multicenter study will receive up to six 21-day treatment cycles. Those who respond well will undergo reduced-dose WBRT and continue selinexor as maintenance therapy. The study will measure how many patients respond to the treatment (overall response rate), how long the response lasts (progression-free survival), overall survival, and safety.
This research aims to provide a less toxic and more effective option for treating CNSL in patients who are older or medically unfit for transplantation.
Detailed description
This is a prospective, investigator-initiated, open-label, single-arm, multicenter phase II clinical trial designed to evaluate the efficacy and safety of a combination regimen consisting of selinexor, high-dose methotrexate (HD-MTX), and rituximab, followed by low-dose whole-brain radiotherapy (WBRT), in patients with newly diagnosed primary or secondary central nervous system lymphoma (PCNSL or SCNSL) who are not eligible for autologous stem cell transplantation (ASCT).
Selinexor is a first-in-class, selective inhibitor of nuclear export (SINE) targeting XPO1/CRM1. By blocking nuclear export, selinexor restores nuclear localization and activity of multiple tumor suppressor proteins and growth regulatory factors. Preclinical studies suggest that selinexor may enhance the antitumor activity of chemotherapy and radiotherapy, particularly in hematologic malignancies. Its role in CNSL is supported by its ability to cross the blood-brain barrier and sensitize lymphoma cells to treatment.
Eligible patients will receive six 21-day cycles of combination therapy: rituximab 375 mg/m² IV on day 0, HD-MTX 3.5 g/m² IV over 4 hours on day 1, and selinexor 80 mg orally once weekly (days 1, 8, and 15). Tumor response will be assessed every three cycles. Patients achieving at least partial response (PR) will proceed to consolidative low-dose WBRT (23.4 Gy in 13 fractions), followed by maintenance selinexor (80 mg orally once weekly) until disease progression or unacceptable toxicity.
The primary endpoint is the overall response rate (ORR) based on the Lugano 2014 criteria. Secondary endpoints include complete response rate (CRR), progression-free survival (PFS), overall survival (OS), and safety/tolerability assessed by CTCAE v5.0.
A total of 26 patients will be enrolled. This study aims to provide an effective treatment option for transplant-ineligible CNSL patients and to explore the potential synergistic effects of selinexor with chemotherapy and radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Selinexor + High-dose Methotrexate + Rituximab + WBRTParticipants in this single-arm study will receive combination therapy as follows: Rituximab 375 mg/m² intravenously on Day 0 of each 21-day cycle High-dose Methotrexate (HD-MTX) 3.5 g/m² intravenously over 4 hours on Day 1 of each cycle Selinexor 80 mg orally once weekly (on Days 1, 8, and 15) during each cycle Treatment is administered every 21 days for up to 6 cycles. Tumor response will be evaluated every 3 cycles. Patients who achieve a partial response (PR) or better will undergo consolidative low-dose whole-brain radiotherapy (WBRT) at 23.4 Gy in 13 fractions. After radiotherapy, patients who maintain a response will continue with maintenance selinexor 80 mg orally once weekly until disease progression, unacceptable toxicity, or withdrawal. This arm is designed to assess the synergistic effect of selinexor when combined with standard CNSL chemotherapy and radiotherapy in patients who are not eligible for stem cell transplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years, male or female.
- Histologically confirmed primary CNS lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL) with CNS-only involvement.
- Ineligible for autologous stem cell transplantation based on clinical assessment or patient refusal.
- At least one measurable brain lesion ≥1 cm in diameter, or positive cerebrospinal fluid (CSF) cytology/flow cytometry for patients with leptomeningeal disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
Key exclusion criteria (17 listed)
- CNS involvement limited to intraocular lymphoma only.
- Prior systemic therapy for CNS lymphoma.
- SCNSL with active systemic (non-CNS) disease involvement.
- Uncontrolled intracranial hypertension.
- Clinically significant or unstable cardiovascular disease, including:
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 + High-dose Methotrexate + Rituximab + WBRTRituximab 375 mg/m² intravenously on Day 0 of each 21-day cycle High-dose Methotrexate (HD-MTX) 3.5 g/m² intravenously over 4 hours on Day 1 of each cycle Selinexor 80 mg orally once weekly (on Days 1, 8, and 15) during each cycle Treatment is administered every 21 days for up to 6 cycles. Tumor response will be evaluated every 3 cycles. Patients who achieve a partial response (PR) or better will undergo consolidative low-dose whole-brain radiotherapy (WBRT) at 23.4 Gy in 13 fractions. | Drug | Experimental Arm |
Primary outcome
ORR
Time frame: 2 years
The proportion of participants who achieve a complete response (CR) or partial response (PR) as assessed by investigators according to the 2014 Lugano classification for lymphoma response evaluation.
1 secondary outcome
PFS
Time frame: 2 years
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 3 Jun 2025.
- Background: PubMed 31907289Houillier C, Soussain C, Ghesquieres H, Soubeyran P, Chinot O, Taillandier L, Lamy T, Choquet S, Ahle G, Damaj G, Agape P, Molucon-Chabrot C, Amiel A, Delwail V, Fabbro M, Jardin F, Chauchet A, Moles-Moreau MP, Morschhauser F, Casasnovas O, Gressin R, Fornecker LM, Abraham J, Marolleau JP, Tempescul A, Campello C, Colin P, Tamburini J, Laribi K, Serrier C, Haioun C, Chebrek S, Schmitt A, Blonski M, Houot R, Boyle E, Bay JO, Oberic L, Tabouret E, Waultier A, Martin-Duverneuil N, Touitou V, Cassoux N, Kas A, Mokhtari K, Charlotte F, Alentorn A, Feuvret L, Le Garff-Tavernier M, Costopoulos M, Mathon B, Peyre M, Delgadillo D, Douzane H, Genet D, Aidaoui B, Hoang-Xuan K, Gyan E. Management and outcome of primary CNS lymphoma in the modern era: An LOC network study. Neurology. 2020 Mar 10;94(10):e1027-e1039. doi: 10.1212/WNL.0000000000008900. Epub 2020 Jan 6.
- Background: PubMed 32536290Walker JS, Garzon R, Lapalombella R. Selinexor for advanced hematologic malignancies. Leuk Lymphoma. 2020 Oct;61(10):2335-2350. doi: 10.1080/10428194.2020.1775210. Epub 2020 Jun 14.
- Background: PubMed 34234609Neupane K, Wahab A, Masood A, Faraz T, Bahram S, Ehsan H, Hannan A, Anwer F. Profile and Management of Toxicity of Selinexor and Belantamab Mafodotin for the Treatment of Triple Class Refractory Multiple Myeloma. J Blood Med. 2021 Jul 1;12:529-550. doi: 10.2147/JBM.S317966. eCollection 2021.
- Background: PubMed 32609814Lurain K, Uldrick TS, Ramaswami R, Polizzotto MN, Goncalves PH, Widell A, Steinberg SM, Jaffe ES, Pittaluga S, Wang HW, Yuan CM, Tamula MA, Martin S, Wolters PL, George J, Little RF, Yarchoan R. Treatment of HIV-associated primary CNS lymphoma with antiretroviral therapy, rituximab, and high-dose methotrexate. Blood. 2020 Nov 5;136(19):2229-2232. doi: 10.1182/blood.2020006048. No abstract available.
- Background: PubMed 33202420Gandhi MK, Hoang T, Law SC, Brosda S, O'Rourke K, Tobin JWD, Vari F, Murigneux V, Fink L, Gunawardana J, Gould C, Oey H, Bednarska K, Delecluse S, Trappe RU, Merida de Long L, Sabdia MB, Bhagat G, Hapgood G, Blyth E, Clancy L, Wight J, Hawkes E, Rimsza LM, Maguire A, Bojarczuk K, Chapuy B, Keane C. EBV-associated primary CNS lymphoma occurring after immunosuppression is a distinct immunobiological entity. Blood. 2021 Mar 18;137(11):1468-1477. doi: 10.1182/blood.2020008520.
- Background: PubMed 34608945Ostrom QT, Cioffi G, Waite K, Kruchko C, Barnholtz-Sloan JS. CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2014-2018. Neuro Oncol. 2021 Oct 5;23(12 Suppl 2):iii1-iii105. doi: 10.1093/neuonc/noab200.
- 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.
Bingzong Li principal investigator
Second Affiliated Hospital of Soochow University
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 Selinexor + High-dose Methotrexate + Rituximab + WBRT in people with Lymphomas, run by Second Affiliated Hospital of Soochow University 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 16 inclusion and 17 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 3 Jun 2025. 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 Bingzong Li (86-512-67784069, lbzwz0907@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07002099, which also lists 6 linked publications.
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 3 Jun 2025.