Primary Central Nervous System LymphomaPhase 2/3NCT07185373
Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed PCNSL
A Phase 2/3 study testing Teniposide, Orelabrutinib and MTX in people with Primary Central Nervous System Lymphoma, run by Huashan Hospital at 15 sites in China.
Trial summary
This is a three-arm, multicenter, randomized controlled trial. Eligible participants will be randomized to one of three induction regimens via stratified block randomization at a 2:2:1 ratio. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Central Nervous System Lymphoma
- What is being tested?
- Teniposide, Orelabrutinib and MTX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 15 sitesChina
- Study dates
- 1 Oct 2025to 30 Jul 2029
- Phase
- Phase 2/3
- 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
- No prior systemic treatment for primary central nervous system lymphoma
- Pathologically confirmed as diffuse large B-cell lymphoma subtype; with sufficient residual surgical specimens remaining after meeting the needs for pathological diagnosis and preservation
- Aged 18-75 years (inclusive)
- ECOG performance status ≤3
- Expected survival time exceeding 3 months
- Major organ functions meeting the following standards:
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- Blood routine parameters (without growth factor support or blood transfusion within the past 7 days; 14 days for pegylated myeloid growth factors): absolute neutrophil count (ANC) ≥1.0×10⁹/L, platelet count (PLT) ≥75×10⁹/L, hemoglobin (Hb) ≥80g/L;
- Blood biochemistry: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN) or ≤3×ULN (for confirmed Gilbert syndrome with direct bilirubin within normal range); aspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5×ULN; serum creatinine within normal range; estimated glomerular filtration rate (eGFR) ≥70ml/min;
- Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5×ULN;
- Ability to tolerate lumbar puncture and/or having an indwelling Ommaya reservoir
- Peripheral blood flow cytometry showed no clonal B cells and no other extramedullary lesions.
- Voluntary signing of a written informed consent form by the participant or their legal representative prior to trial screening, indicating their understanding of the study purpose, necessary procedures, and willingness to comply with the protocol and attend follow-up visits
Who cannot join
- Lymphoma involving sites outside the central nervous system (CNS)
- Patients with a previous history of tumors
- Patients with intraocular lymphoma or suspected diagnosis of intraocular lymphoma invasion
- Uncontrolled or significant cardiovascular diseases, including:
- New York Heart Association (NYHA) class Ⅲ-Ⅳ congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first administration of study drugs; clinically significant or treatment-requiring arrhythmias at screening; left ventricular ejection fraction (LVEF) <50%; or patients with controlled coronary heart disease who are either not using anticoagulants/antiplatelet drugs or taking 2 or more anticoagulants/antiplatelet drugs orally.
- Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy).
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- A history of clinically significant QTc interval prolongation, or QTc interval (calculated via Bazett's formula using manually collected screening data) >470ms in females or >450ms in males.
- Refractory hypertension (blood pressure not controlled despite ≥1 month of optimal, tolerable doses of 2 or more antihypertensive drugs [including diuretics] with lifestyle modifications; or blood pressure controlled only with 3 or more antihypertensive drugs).
- Active bleeding within 2 months prior to screening; use of anticoagulants/antiplatelet drugs for <6 months; or a definite bleeding tendency as judged by the investigator (e.g., bleeding-risk esophageal varices, active local ulcer lesions).
- Diabetic patients whose blood sugar remains poorly controlled after insulin treatment
- A history of stroke or intracranial hemorrhage within 6 months prior to screening, excluding postoperative sequelae-related intracranial hemorrhage
- A history of organ transplantation or allogeneic bone marrow transplantation
- Surgical procedures within 6 weeks prior to screening (diagnostic examinations are not considered surgical procedures; insertion of vascular access devices is exempt from this exclusion criterion).
- Use of Chinese herbal medicines with anti-tumor effects (as specified in the package insert, e.g., Compound Cantharidin Capsules) within 4 weeks prior to screening
- Active or uncontrolled hepatitis B virus (HBV) infection (HBsAg positive and/or HBcAb positive with positive HBV DNA titer); HCV Ab positive; HIV positive. The following patients can be provisioned for continuous observation pending enrollment when given prophylactic anti-HBV (such as entecavir or tenofovir), including :
- HBsAg positive with negative HBV DNA titer.
- HBsAg negative, HBsAb negative, HBcAb positive, and negative HBV DNA titer Patients with positive HBV-DNA can be considered for enrollment only when the HBV-DNA value is less than 500IU/mL after treatment
- Uncontrolled active systemic fungal, bacterial, viral, or other infections (defined as persistent infection-related symptoms/signs that do not improve despite appropriate antibiotic or other treatments) or requiring intravenous antibiotics
- Administration of live vaccines or immunological agents within 4 weeks prior to enrollment.
- Need for concurrent and continuous use of drugs with moderate/strong inhibitory or inductive effects on cytochrome P450 CYP3A.
- Patients with hypersensitivity to orelabrutinib or its excipients (e.g., immediate or accelerated allergic reactions).
- Patients with hypersensitivity to teniposide or its excipients (e.g., immediate or accelerated allergic reactions)
- Clinically significant gastrointestinal abnormalities that may affect drug intake, transit, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or participants with total gastrectomy.
- Participants with a history or current presence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia with severely impaired lung function, etc
- Participants with chronic liver damage, severe fatty liver, or alcoholic liver disease.
- Pregnant or lactating women; women of childbearing age who are unwilling to use contraception from the time of enrollment until 180 days after the last dose of the study drug (serum pregnancy test results must be negative within 14 days before the start of study drug treatment for women of childbearing potential); men who are not surgically sterilized and unwilling to use contraception during the study and until 180 days after the last dose of the study drug.
- Presence of life-threatening diseases or severe organ dysfunction, deemed unsuitable for participation in the trial by the investigator.
- Any mental or cognitive impairment that may limit the understanding and execution of the informed consent form or adherence to the study
- Previous receipt of whole-brain radiotherapy for primary central nervous system lymphoma.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Not yet recruiting
Peking University Third Hospital
Beijing
Hongmei Jing
- Recruiting
Xuanwu Hospital
Beijing
Wanling Sun
- Recruiting
Huaxi Hospital
Chengdu
ming jiang
- Not yet recruiting
First Affiliated Hospital of Fujian Medical University
Fuzhou
Ting Yang
- Not yet recruiting
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou
Yudan Wu
- Recruiting
Department of Hematology, Qilu Hospital of Shandong University
Jinan
jingjing ye
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
Fei Li
- Not yet recruiting
The Tumor Hospital of Jiangsu Province
Nanjing
Jianqiu Wu
- Not yet recruiting
Changhai Hospital
Shanghai
Xiong Ni
- Recruiting
Huashan Hospital
Shanghai
Tong Chen
- Not yet recruiting
RenJi Hospital
Shanghai
Honghui Huang
- Recruiting
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai
Bing Xiu
- Recruiting
WuhanUnionHospital
Wuhan
Jun Fang
- Recruiting
Tang-Du Hospital
Xi'an
Weiwei Qin
- Recruiting
Henan Cancer Hospital
Zhengzhou
Keshu Zhou
About this study
Official title: Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed Primary Central Nervous System Lymphoma-A Randomized Controlled Trial
This is a three-arm, multicenter, randomized controlled trial. Eligible participants will be randomized to one of three induction regimens via stratified block randomization at a 2:2:1 ratio.
Induction regimens:
Read more
Arm A: Teniposide + orelabrutinib + rituximab + methotrexate (MTX) + dexamethasone, administered in 21-day cycles.
Arm B: Orelabrutinib + rituximab + MTX + dexamethasone, administered in 21-day cycles.
Arm C: Rituximab + MTX + dexamethasone, administered in 21-day cycles. Participants achieving complete response (CR) or unconfirmed complete response (CRu) post-induction will proceed to consolidation therapy, with options including: MTX + rituximab (once every 3 months for 1 year); high-dose chemotherapy followed by autologous stem cell transplantation (ASCT); dose-reduced whole brain radiotherapy; or other modalities (as determined by the investigator).
Read the detailed description
This is a three-arm, multicenter, randomized controlled trial. Eligible participants (meeting inclusion and exclusion criteria) will be assigned to one of three induction regimens via stratified block randomization at a 2:2:1 ratio. Stratification will be based on two factors: age (≤60 vs. >60 years) and ECOG performance status (0-1 vs. 2-3).
Induction regimens:
Arm A: Teniposide, orelabrutinib, rituximab, methotrexate (MTX) and dexamethasone (21-day cycle).
Arm B: Orelabrutinib, rituximab, MTX and dexamethasone (21-day cycle). Arm C: Rituximab, MTX and dexamethasone (21-day cycle).
Following induction therapy, participants achieving complete response (CR) or unconfirmed complete response (CRu) will receive consolidation therapy. Four options are available, with selection determined by investigators based on individual patient conditions in real-world practice:
Chemotherapy (MTX + rituximab, administered once every 3 months for 1 year); High-dose chemotherapy conditioning followed by autologous stem cell transplantation (ASCT); dose-reduced whole brain radiotherapy; Other consolidation modalities. Participants who do not achieve CR or CRu after induction therapy will be eligible for alternative anti-primary central nervous system lymphoma (anti-PCNSL) treatments, as determined by investigators based on individual clinical status.
- Conditions
- Primary Central Nervous System Lymphoma
- Being tested
- Teniposide, Orelabrutinib, MTX, Rituximab (R), Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeniposideDrug
This trial enrolls eligible participants (meeting inclusion and exclusion criteria), who will be randomized to one of three induction regimens via stratified block randomization at a 2:2:1 ratio. Stratification factors include age (≤60 vs. >60 years) and ECOG performance status (0-1 vs. 2-3). Within each stratum, blocks of size 15 will be used to ensure balanced allocation.
Induction regimens:
Arm A: Teniposide, orelabrutinib, rituximab, methotrexate (MTX) and dexamethasone, administered in 21-day cycles.
Arm B: Orelabrutinib, rituximab, MTX and dexamethasone, administered in 21-day cycles.
Arm C: Rituximab, MTX and dexamethasone, administered in 21-day cycles. Following induction therapy, participants achieving complete response (CR) or unconfirmed complete response (CRu) will proceed to consolidation therapy.
OrelabrutinibDrug
This trial enrolls eligible participants (meeting inclusion and exclusion criteria), who will be randomized to one of three induction regimens via stratified block randomization at a 2:2:1 ratio. Stratification factors include age (≤60 vs. >60 years) and ECOG performance status (0-1 vs. 2-3). Within each stratum, blocks of size 15 will be used to ensure balanced allocation.
Induction regimens:
Arm A: Teniposide, orelabrutinib, rituximab, methotrexate (MTX) and dexamethasone, administered in 21-day cycles.
Arm B: Orelabrutinib, rituximab, MTX and dexamethasone, administered in 21-day cycles.
Arm C: Rituximab, MTX and dexamethasone, administered in 21-day cycles. Following induction therapy, participants achieving complete response (CR) or unconfirmed complete response (CRu) will proceed to consolidation therapy.
MTXDrug
This trial enrolls eligible participants (meeting inclusion and exclusion criteria), who will be randomized to one of three induction regimens via stratified block randomization at a 2:2:1 ratio. Stratification factors include age (≤60 vs. >60 years) and ECOG performance status (0-1 vs. 2-3). Within each stratum, blocks of size 15 will be used to ensure balanced allocation.
Induction regimens:
Arm A: Teniposide, orelabrutinib, rituximab, methotrexate (MTX) and dexamethasone, administered in 21-day cycles.
Arm B: Orelabrutinib, rituximab, MTX and dexamethasone, administered in 21-day cycles.
Arm C: Rituximab, MTX and dexamethasone, administered in 21-day cycles. Following induction therapy, participants achieving complete response (CR) or unconfirmed complete response (CRu) will proceed to consolidation therapy.
Rituximab (R)Drug
This trial enrolls eligible participants (meeting inclusion and exclusion criteria), who will be randomized to one of three induction regimens via stratified block randomization at a 2:2:1 ratio. Stratification factors include age (≤60 vs. >60 years) and ECOG performance status (0-1 vs. 2-3). Within each stratum, blocks of size 15 will be used to ensure balanced allocation.
Induction regimens:
Arm A: Teniposide, orelabrutinib, rituximab, methotrexate (MTX) and dexamethasone, administered in 21-day cycles.
Arm B: Orelabrutinib, rituximab, MTX and dexamethasone, administered in 21-day cycles.
Arm C: Rituximab, MTX and dexamethasone, administered in 21-day cycles. Following induction therapy, participants achieving complete response (CR) or unconfirmed complete response (CRu) will proceed to consolidation therapy.
DexamethasoneDrug
This trial enrolls eligible participants (meeting inclusion and exclusion criteria), who will be randomized to one of three induction regimens via stratified block randomization at a 2:2:1 ratio. Stratification factors include age (≤60 vs. >60 years) and ECOG performance status (0-1 vs. 2-3). Within each stratum, blocks of size 15 will be used to ensure balanced allocation.
Induction regimens:
Arm A: Teniposide, orelabrutinib, rituximab, methotrexate (MTX) and dexamethasone, administered in 21-day cycles.
Arm B: Orelabrutinib, rituximab, MTX and dexamethasone, administered in 21-day cycles.
Arm C: Rituximab, MTX and dexamethasone, administered in 21-day cycles. Following induction therapy, participants achieving complete response (CR) or unconfirmed complete response (CRu) will proceed to consolidation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Teniposide, orelabrutinib, rituximab, methotrexate (MTX), and dexamethasone (21-day cycle). Receives: Drug: Teniposide; Drug: Orelabrutinib; Drug: MTX; Drug: Rituximab (R); Drug: Dexamethasone |
| Arm B | Experimental | Orelabrutinib, rituximab, MTX and dexamethasone (21-day cycle). Receives: Drug: Orelabrutinib; Drug: MTX; Drug: Rituximab (R); Drug: Dexamethasone |
| Arm C | Active comparator | Rituximab, MTX and dexamethasone (21-day cycle) Receives: Drug: MTX; Drug: Rituximab (R); Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of CR/CRu in Arm A versus Arm C during the induction therapy phase
Efficacy evaluation will be determined in accordance with the IPCG criteria
Measured: At the end of Cycle6 (each cycle is 21 days)
The proportion of CR/CRu in Arm A versus Arm B during the induction therapy phase
Efficacy evaluation will be determined in accordance with the IPCG criteria
Measured: At the end of Cycle6 (each cycle is 21 days)
Secondary outcomes (3)
Overall response rate (ORR) during induction therapy
Efficacy evaluation will be determined in accordance with the IPCG criteria
Measured: At the end of Cycle6 (each cycle is 21 days)
proportion of CR/CRu in Arm B versus Arm C during the induction therapy phase
Efficacy evaluation will be determined in accordance with the IPCG criteria
Measured: At the end of Cycle6 (each cycle is 21 days)
Progression-free survival (PFS)
Efficacy evaluation will be determined in accordance with the IPCG criteria
Measured: 2 years after Day 1 Cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Oct 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Jul 2029 (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 LymphomaStudies of the same condition, open and under way.
- More trials run by Huashan 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, Xuanwu Hospital, Beijing, The First Affiliated Hospital of Nanchang University, Shanghai Tongji Hospital, Tongji University School of Medicine, Huaxi Hospital, WuhanUnionHospital, Tang-Du Hospital, The Tumor Hospital of Jiangsu Province, Changhai Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, RenJi Hospital, Henan Cancer Hospital, First Affiliated Hospital of Fujian Medical University, Peking University Third Hospital
- Responsible party
- Principal investigator, Tong Chen, MD, Huashan Hospital
- Investigators
- Tong Chen, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185373
- Sponsor's protocol ID
- KY2025-725
- Status last verified
- Aug 2026
- First submitted
- 11 Sep 2025
- Last updated
- 19 Aug 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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed Primary Central Nervous System Lymphoma-A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07185373
- Acronym / sponsor ID
- KY2025-725
- Conditions
- Primary Central Nervous System Lymphoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, Xuanwu Hospital, Beijing, The First Affiliated Hospital of Nanchang University, Shanghai Tongji Hospital, Tongji University School of Medicine, Huaxi Hospital, WuhanUnionHospital, Tang-Du Hospital, The Tumor Hospital of Jiangsu Province, Changhai Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, RenJi Hospital, Henan Cancer Hospital, First Affiliated Hospital of Fujian Medical University, Peking University Third Hospital
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 22 Sep 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 is a three-arm, multicenter, randomized controlled trial. Eligible participants will be randomized to one of three induction regimens via stratified block randomization at a 2:2:1 ratio.
Induction regimens:
Arm A: Teniposide + orelabrutinib + rituximab + methotrexate (MTX) + dexamethasone, administered in 21-day cycles.
Arm B: Orelabrutinib + rituximab + MTX + dexamethasone, administered in 21-day cycles.
Arm C: Rituximab + MTX + dexamethasone, administered in 21-day cycles. Participants achieving complete response (CR) or unconfirmed complete response (CRu) post-induction will proceed to consolidation therapy, with options including: MTX + rituximab (once every 3 months for 1 year); high-dose chemotherapy followed by autologous stem cell transplantation (ASCT); dose-reduced whole brain radiotherapy; or other modalities (as determined by the investigator).
Detailed description
This is a three-arm, multicenter, randomized controlled trial. Eligible participants (meeting inclusion and exclusion criteria) will be assigned to one of three induction regimens via stratified block randomization at a 2:2:1 ratio. Stratification will be based on two factors: age (≤60 vs. >60 years) and ECOG performance status (0-1 vs. 2-3).
Induction regimens:
Arm A: Teniposide, orelabrutinib, rituximab, methotrexate (MTX) and dexamethasone (21-day cycle).
Arm B: Orelabrutinib, rituximab, MTX and dexamethasone (21-day cycle). Arm C: Rituximab, MTX and dexamethasone (21-day cycle).
Following induction therapy, participants achieving complete response (CR) or unconfirmed complete response (CRu) will receive consolidation therapy. Four options are available, with selection determined by investigators based on individual patient conditions in real-world practice:
Chemotherapy (MTX + rituximab, administered once every 3 months for 1 year); High-dose chemotherapy conditioning followed by autologous stem cell transplantation (ASCT); dose-reduced whole brain radiotherapy; Other consolidation modalities. Participants who do not achieve CR or CRu after induction therapy will be eligible for alternative anti-primary central nervous system lymphoma (anti-PCNSL) treatments, as determined by investigators based on individual clinical status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Teniposide, Drug: Orelabrutinib, Drug: MTX, Drug: Rituximab (R), Drug: DexamethasoneTeniposide, orelabrutinib, rituximab, methotrexate (MTX), and dexamethasone (21-day cycle). |
| Arm B | Experimental | Drug: Orelabrutinib, Drug: MTX, Drug: Rituximab (R), Drug: DexamethasoneOrelabrutinib, rituximab, MTX and dexamethasone (21-day cycle). |
| Arm C | Active comparator | Drug: MTX, Drug: Rituximab (R), Drug: DexamethasoneRituximab, MTX and dexamethasone (21-day cycle) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- No prior systemic treatment for primary central nervous system lymphoma
- Pathologically confirmed as diffuse large B-cell lymphoma subtype; with sufficient residual surgical specimens remaining after meeting the needs for pathological diagnosis and preservation
- Aged 18-75 years (inclusive)
- ECOG performance status ≤3
- Expected survival time exceeding 3 months
Key exclusion criteria (29 listed)
- Lymphoma involving sites outside the central nervous system (CNS)
- Patients with a previous history of tumors
- Patients with intraocular lymphoma or suspected diagnosis of intraocular lymphoma invasion
- Uncontrolled or significant cardiovascular diseases, including:
- Active bleeding within 2 months prior to screening; use of anticoagulants/antiplatelet drugs for <6 months; or a definite bleeding tendency as judged by the investigator (e.g., bleeding-risk esophageal varices, active local ulcer lesions).
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 |
|---|---|---|
| TeniposideThis trial enrolls eligible participants (meeting inclusion and exclusion criteria), who will be randomized to one of three induction regimens via stratified block randomization at a 2:2:1 ratio. Stratification factors include age (≤60 vs. >60 years) and ECOG performance status (0-1 vs. 2-3). Within each stratum, blocks of size 15 will be used to ensure balanced allocation. Induction regimens: Arm A: Teniposide, orelabrutinib, rituximab, methotrexate (MTX) and dexamethasone, administered in 21-day cycles. Arm B: Orelabrutinib, rituximab, MTX and dexamethasone, administered in 21-day cycles. Arm C: Rituximab, MTX and dexamethasone, administered in 21-day cycles. Following induction therapy, participants achieving complete response (CR) or unconfirmed complete response (CRu) will proceed to consolidation therapy. | Drug | Arm A |
| OrelabrutinibThis trial enrolls eligible participants (meeting inclusion and exclusion criteria), who will be randomized to one of three induction regimens via stratified block randomization at a 2:2:1 ratio. Stratification factors include age (≤60 vs. >60 years) and ECOG performance status (0-1 vs. 2-3). Within each stratum, blocks of size 15 will be used to ensure balanced allocation. Induction regimens: Arm A: Teniposide, orelabrutinib, rituximab, methotrexate (MTX) and dexamethasone, administered in 21-day cycles. Arm B: Orelabrutinib, rituximab, MTX and dexamethasone, administered in 21-day cycles. Arm C: Rituximab, MTX and dexamethasone, administered in 21-day cycles. Following induction therapy, participants achieving complete response (CR) or unconfirmed complete response (CRu) will proceed to consolidation therapy. | Drug | Arm A, Arm B |
| MTXThis trial enrolls eligible participants (meeting inclusion and exclusion criteria), who will be randomized to one of three induction regimens via stratified block randomization at a 2:2:1 ratio. Stratification factors include age (≤60 vs. >60 years) and ECOG performance status (0-1 vs. 2-3). Within each stratum, blocks of size 15 will be used to ensure balanced allocation. Induction regimens: Arm A: Teniposide, orelabrutinib, rituximab, methotrexate (MTX) and dexamethasone, administered in 21-day cycles. Arm B: Orelabrutinib, rituximab, MTX and dexamethasone, administered in 21-day cycles. Arm C: Rituximab, MTX and dexamethasone, administered in 21-day cycles. Following induction therapy, participants achieving complete response (CR) or unconfirmed complete response (CRu) will proceed to consolidation therapy. | Drug | Arm A, Arm B, Arm C |
| Rituximab (R)This trial enrolls eligible participants (meeting inclusion and exclusion criteria), who will be randomized to one of three induction regimens via stratified block randomization at a 2:2:1 ratio. Stratification factors include age (≤60 vs. >60 years) and ECOG performance status (0-1 vs. 2-3). Within each stratum, blocks of size 15 will be used to ensure balanced allocation. Induction regimens: Arm A: Teniposide, orelabrutinib, rituximab, methotrexate (MTX) and dexamethasone, administered in 21-day cycles. Arm B: Orelabrutinib, rituximab, MTX and dexamethasone, administered in 21-day cycles. Arm C: Rituximab, MTX and dexamethasone, administered in 21-day cycles. Following induction therapy, participants achieving complete response (CR) or unconfirmed complete response (CRu) will proceed to consolidation therapy. | Drug | Arm A, Arm B, Arm C |
| DexamethasoneThis trial enrolls eligible participants (meeting inclusion and exclusion criteria), who will be randomized to one of three induction regimens via stratified block randomization at a 2:2:1 ratio. Stratification factors include age (≤60 vs. >60 years) and ECOG performance status (0-1 vs. 2-3). Within each stratum, blocks of size 15 will be used to ensure balanced allocation. Induction regimens: Arm A: Teniposide, orelabrutinib, rituximab, methotrexate (MTX) and dexamethasone, administered in 21-day cycles. Arm B: Orelabrutinib, rituximab, MTX and dexamethasone, administered in 21-day cycles. Arm C: Rituximab, MTX and dexamethasone, administered in 21-day cycles. Following induction therapy, participants achieving complete response (CR) or unconfirmed complete response (CRu) will proceed to consolidation therapy. | Drug | Arm A, Arm B, Arm C |
Primary outcome
The proportion of CR/CRu in Arm A versus Arm C during the induction therapy phase
Time frame: At the end of Cycle6 (each cycle is 21 days)
Efficacy evaluation will be determined in accordance with the IPCG criteria
The proportion of CR/CRu in Arm A versus Arm B during the induction therapy phase
Time frame: At the end of Cycle6 (each cycle is 21 days)
Efficacy evaluation will be determined in accordance with the IPCG criteria
3 secondary outcomes
Overall response rate (ORR) during induction therapy
Time frame: At the end of Cycle6 (each cycle is 21 days)
proportion of CR/CRu in Arm B versus Arm C during the induction therapy phase
Time frame: At the end of Cycle6 (each cycle is 21 days)
Progression-free survival (PFS)
Time frame: 2 years after Day 1 Cycle 1
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 19 Aug 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.
Tong Chen principal investigator
Huashan Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Teniposide, Orelabrutinib and MTX in people with Primary Central Nervous System Lymphoma, run by Huashan Hospital at 15 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 12 inclusion and 29 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Tong Chen (+86-021-52887102, chentong@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of CR/CRu in Arm A versus Arm C during the induction therapy phase (time frame: At the end of Cycle6 (each cycle is 21 days)). The study lists 2 primary outcomes in all. 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 19 Aug 2026.