Primary Central Nervous System Lymphoma

21

Review clinical trials related to Primary Central Nervous System Lymphoma. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

A Study of Epcoritamab and Ibrutinib in People With Central Nervous System Lymphoma (CNSL)

The purpose of this study is to find out whether the combination of epcoritamab and ibrutinib is a safe treatment approach that causes few or mild side effects in people with relapsed/refractory primary central nervous system lymphoma (PCNSL) or secondary central nervous system lymphoma (SCNSL).

Participants needed: 26
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Memorial Sloan Kettering Cancer CenterUpdated: Jun 11, 2026Locations: 8
Eligibility criteria

>/= 18 years of age on the day of consenting to the study. [+13]

Newly diagnosed PCNSLs or SCNSLs and patients with non-CNS disease are excluded. [+36]

Status: Recruiting

A Multicenter, Prospective Clinical Trial With a Concurrent Control Evaluating Methotrexate Combined With Rituximab,Sintilimab and Pirtobrutinib vs. Investigator-Selected Standard of Care in Treatment-Naive PCNSL

The goal of this clinical trial is to evaluate the efficacy and safety of a four-drug combination regimen as first-line treatment for adults aged 18 years and older with newly diagnosed primary central nervous system lymphoma (PCNSL). The main questions it aims to answer are: Does the combination of pirtobrutinib, sintilimab, rituximab, and high-dose methotrexate achieve a higher complete response rate than standard treatment for newly diagnosed PCNSL? What is the safety and tolerability profile of this four-drug combination regimen? Researchers will compare the experimental four-drug combination to investigator-selected standard-of-care regimens (all based on high-dose methotrexate) to see if the experimental regimen improves complete response rate, progression-free survival, and overall survival while maintaining an acceptable safety profile. Participants will: Be assigned to either the experimental group or the standard treatment group based on their personal preference Receive 6 cycles of induction therapy (21 days per cycle) with their assigned treatment regimen Undergo regular clinical assessments, including contrast-enhanced brain MRI scans, blood tests, and cerebrospinal fluid examinations Complete the EORTC QLQ-C30 quality-of-life questionnaire at baseline, mid-treatment, end of treatment, and follow-up visits Receive optional consolidation or maintenance therapy based on their response to induction treatment Be followed for up to 2 years after completing treatment to monitor for disease progression and long-term outcomes

Participants needed: 77
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Tongji HospitalUpdated: Jun 2, 2026Locations: 4
Eligibility criteria

Age >= 18 years. [+11]

myocardial infarction, unstable angina within 6 months before first dose; arrhyt... [+4]

Status: Recruiting

Zanubrutinib With Pemetrexed to Treat Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphomas

This study is being conducted to evaluate the safety and efficacy of the combination of pemetrexed and zanubrutinib (called induction therapy) followed by zanubrutinib treatment alone (also called maintenance therapy) in people who have relapsed or refractory (RR) primary central nervous system lymphoma (PCNSL) or isolated central nervous system relapse of B cell lymphoma (SCNSL). Assessments include how well people respond to this treatment, whether their disease gets better or worse, and their survival. Safety of this treatment and its side effects also will be assessed.

Participants needed: 15
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Baptist Health South FloridaUpdated: Mar 3, 2026Locations: 1
Eligibility criteria

Primary CNS lymphoma or isolated secondary CNS involvement by diffuse large B ce... [+22]

Serious uncontrolled concurrent illness or comorbid condition [+25]

Status: Recruiting

Pembrolizumab + Chemotherapy in Newly Diagnosed PCNSL

This research study is studying if the investigational drug, Pembrolizumab, in combination with chemotherapy helps primary central nervous system lymphoma with acceptable side effects. This research study involves a combination of the below drugs: * Pembrolizumab (a type of monoclonal antibody) * Methotrexate (a type of anti-metabolite) * Temozolomide (a type of alkylating agent) * Rituximab (a type of antibody)

Participants needed: 15
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Dana-Farber Cancer InstituteUpdated: Feb 20, 2026Locations: 2
Eligibility criteria

Brain biopsy or resection [+51]

Participants who cannot undergo MRI [+18]

Status: Recruiting

Pembrolizumab, Ibrutinib and Rituximab in PCNSL

This research study is evaluating a combination therapy of 3 drugs as possible treatments for recurrent primary central nervous system lymphoma (PCNSL). The three drugs being used in the study are: * Pembrolizumab (MK3475) * Ibrutinib * Rituximab (or biosimilar)

Participants needed: 37
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Dana-Farber Cancer InstituteUpdated: Feb 20, 2026Locations: 4
Eligibility criteria

Participant must be able to understand and willing to sign a written informed co... [+53]

Patients who cannot undergo MRI brain [+32]

Status: Not yet recruiting

Methotrexate Early Toxicity Monitoring

High-dose methotrexate (MTX) is the main componement of first line treatment in primary central nervous system lymphoma. Renal toxicity is the main dose limiting toxicity because of major MTX elimination by the kidneys. MTX crystallizes in renal tubules, leading to a renal failure (RF) and further delaying its elimination. When RF occurs, MTX accumulates, prolonging the duration of treatment exposure. MTX prolonging exposure can cause life-threatening complications and delay further treatments in the patient. Preventive measures have been developped, such as alkaline fluid hyperhydration and folic acid administration, to try to reduce the risk of these adverse events. In suspected severe RF in link to MTX is suspected, glucarpidase can be administared. However, this is an expensive treatment and not all patients recover normal renal function despite its use. MTX is an essential treatment for the management of PCNSL which is currently a curable disease especially in patients who are able to receive a consolidation treatment as thiotepa-based intensive consolidation followed by autologous stem cell transplantation (IC-ASCT). IC-ASCT requires a normal renal function, which could be impaired by severe RF secondary to MTX. The purpose of the study is to investigate how early dosing MTX could be used to simulate late concentrations. Early monitoring of MTX elimination could be implemented to identify patients at risk of delayed elimination and thus introduce rapid mesures as early administration of glucarpidase.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Assistance Publique Hopitaux De MarseilleUpdated: Feb 12, 2026Locations: 1
Eligibility criteria

Adult patient aged 18 years or older, [+4]

Patient treated with a therapy complementary to the standard 1st-line treatment... [+2]

Status: Recruiting

Glofitamab With Obinutuzumab Pre-treatment for the Treatment of Central Nervous System Lymphoma

This phase Ib trial tests the safety and side effects of glofitamab after pre-treatment with obinutuzumab and how well they work in treating patients with central nervous system (CNS) lymphoma. Glofitamab is a bispecific antibody that can bind to two different antigens (substances that cause the body to make a specific immune response) at the same time. Glofitamab binds to CD20 on lymphoma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Obinutuzumab can also be administered as a pre-treatment to make glofitamab safer and more tolerable. Giving glofitamab with obinutuzumab pre-treatment may be safe, tolerable, and/or effective in treating patients with CNS lymphoma.

Participants needed: 20
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: City of Hope Medical CenterUpdated: Nov 10, 2025Locations: 1
Eligibility criteria

Documented informed consent of the participant and/or legally authorized represe... [+44]

Contraindication to any of the individual components of glofitamab or history of... [+40]

Status: Recruiting

Q702 for the Treatment of Patients With Hematologic Malignancies

This phase I trial tests the safety, side effects, and best dose of Q702 in treating patients with hematologic malignancies. Q702 is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Giving Q702 may be safe, tolerable and/or effective in treating patients with hematologic malignancies.

Participants needed: 46
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Mayo ClinicUpdated: Oct 10, 2025Locations: 2
Eligibility criteria

PRE-REGISTRATION: Age ≥ 18 years [+38]

PRE-REGISTRATION: Myeloproliferative neoplasm (MPN) patients with known active C... [+30]

Status: Not yet recruiting

Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed PCNSL

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).

Participants needed: 215
Trial details
Phase: Phase 2, Phase 3Age: 18-75Biological sex: AllType: InterventionalSponsor: Huashan HospitalUpdated: Sep 22, 2025Locations: 2
Eligibility criteria

No prior systemic treatment for primary central nervous system lymphoma [+10]

Lymphoma involving sites outside the central nervous system (CNS) [+26]

Status: Recruiting

Paxalisib (GDC-0084) In Recurrent Or Refractory PCNSL

This research study is studying a drug called Paxalisib (GDC-0084) as a possible treatment for primary central nervous system lymphoma (PCNSL)

Participants needed: 25
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Lakshmi Nayak, MDUpdated: Jun 26, 2025Locations: 2
Eligibility criteria

Participants must be able to understand and willing to sign a written informed c... [+25]

Participants unable to undergo MRI brain. [+15]

Status: Recruiting

Maintenance Obinutuzumab in Treating Patients With Central Nervous System Lymphoma Who Have Achieved a Complete or Partial Response

This randomized phase II trial studies how well obinutuzumab works as maintenance treatment in patients with central nervous system lymphoma who have achieved the disappearance of all signs of cancer in response to treatment (complete response) or a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment (partial response). Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread.

Participants needed: 28
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Providence Health & ServicesUpdated: Jun 5, 2025Locations: 7
Eligibility criteria

CD20+ B-cell primary central nervous system lymphoma (PCNSL) confirmed at the ti... [+14]

History of severe allergic or anaphylactic reactions to monoclonal antibody ther... [+11]

Status: Recruiting

Rituximab, Lenalidomide Combined With Methotrexate and Temozolomide For Primary Central Nervous System Lymphoma

This is a prospective single arm, multi-center, phase II clinical trial to observe the efficacy and safety of Rituximab, Lenalidomide combined with high-dose Methotrexate and Temozolomide (RL-MT) in the first-line treatment for patients with primary central nervous system lymphoma.

Participants needed: 30
Trial details
Phase: Phase 2Age: 18-70Biological sex: AllType: InterventionalSponsor: Henan Cancer HospitalUpdated: Apr 23, 2025Locations: 1
Eligibility criteria

Age between 18 to 70 years old (including 18 and 70) [+8]

Diagnosed as secondary central nervous system lymphoma [+13]

Status: Recruiting

Tirabrutinib Maintenance Versus Placebo in Patients With Primary CNS Lymphoma in Complete Remission (JCOG2104)

A double-blind, randomized phase II comparative trial will evaluate the superiority of the investigational treatment (tirabrutinib maintenance therapy) over standard care (observation with placebo) in terms of progression-free survival in patients with newly diagnosed primary central nervous system lymphoma (PCNSL) who have achieved complete response (CR or CRu) following induction therapy with high-dose methotrexate (HD-MTX)-based chemotherapy and have not undergone consolidative whole-brain irradiation. Participants will: Take protocol drug tirabrutinib or a placebo every day until disease progression or experience of unacceptable toxicity. Visit the clinic once every 4 weeks for checkups and tests, as well as protocol drug prescription.

Participants needed: 92
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Kyorin UniversityUpdated: Apr 23, 2025Locations: 1
Eligibility criteria

Histopathological diagnosis of B cell lymphoma. [+14]

Synchronous or metachronous malignancies. [+23]

Status: Recruiting

Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) Regimen As First-line Therapy for PCNS DLBCL

This study aims to observe and explore the efficacy and safety of Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) regimen as first-line therapy for primary central nervous system diffuse large B-cell lymphomas(PCNS DLBCL)

Participants needed: 44
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Zhejiang Cancer HospitalUpdated: Feb 18, 2025Locations: 1
Eligibility criteria

Patients voluntarily joined the study, signed the informed consent, and had good... [+5]

Patients who have previously received antitumor therapy or targeted therapy [+6]

Status: Recruiting

Adjusted High-dose Chemotherapy With Autologous Stem Cell Transplant vs. Conventional Immunochemotherapy in Elderly PCNSL Patients

Most patients being diagnosed with primary diffuse large B-cell lymphoma of the central nervous system (PCNSL) are 60 years or older. Elderly patients with PCNSL have a poor prognosis and there is a great medical need to improve outcome for this vulnerable population. In Germany and many international centres, there are currently two widely used strategies to treat elderly PCNSL patients who are eligible for high-dose methotrexate (HD-MTX) treatment, which have not yet been compared head-to-head. The R-MP regimen has been established by the Cooperative PCNSL Study Group as a "conventional" immunochemotherapy standard treatment for elderly patients with newly diagnosed disease and consists of Rituximab, HD-MTX and Procarbazine followed by maintenance therapy with Procarbazine. In contrast, another recently established protocol also includes HD-MTX-based induction therapy, but followed by consolidating high-dose chemotherapy and autologous stem cell transplantation (HCT-ASCT). This is an overall more intensive, but substantially shorter treatment approach, feasible for elderly patients being considered eligible for a more intensive treatment. The PRIMA-CNS trial aims to compare these two treatment approaches with respect to survival, response rates and toxicity.

Participants needed: 340
Trial details
Phase: Phase 3Age: 65+Biological sex: AllType: InterventionalSponsor: University Hospital FreiburgUpdated: Feb 17, 2025Locations: 35
Eligibility criteria

Immunocompetent patients with newly-diagnosed primary DLBCL of the central nervo... [+10]

Congenital or acquired immunodeficiency including HIV infection and previous org... [+18]

Status: Recruiting

Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma

This is a single arm open-label multicenter phase I/II investigation of combination lenalidomide/Tafasitamab in patients with relapsed central nervous system (CNS) lymphoma. This is the first study to examine a naked anti-CD19 monoclonal antibody in relapsed CNS lymphoma patients as well as the combination of anti-CD19 antibody plus an Immunomodulatory imide drugs (IMiDs) in CNS lymphomas. This study will also test the novel hypothesis that Tafasitamab enhances blood-brain barrier permeability, a potential property that could have broad clinical implications.

Participants needed: 35
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: James RubensteinUpdated: Feb 3, 2025Locations: 1
Eligibility criteria

Participants must have relapsed primary or secondary CNS lymphoma, diffuse large... [+21]

Has received systemic anti-cancer therapies within 2 weeks of first dose, radiat... [+9]

Status: Recruiting

Camrelizumab for Patients with Recurrent Primary Central Nervous System Lymphoma (PCNSL)

This study is intend to improve the objective response rate in treatment of camrelizumab in recurrent primary central nervous system lymphoma patients.

Participants needed: 21
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Beijing Sanbo Brain HospitalUpdated: Oct 15, 2024Locations: 1
Eligibility criteria

The initial diagnosis was primary diffuse large B-cell lymphoma of the central n... [+8]

Concurrent administration of any other antitumor therapy; [+8]

Status: Recruiting

Orelabrutinib,Rituximab and Methotrexate in Newly Diagnosed Primary Central Nervous System Lymphoma

It is a single arm, multicenter, phase 2 study to explore the efficacy and safety study of OR-MTX chemotherapy(Orelabrutinib, Rituximab and Methotrexate)as first-line regimens in the treatment of newly diagnosed primary central nervous system lymphoma. Objective response rate is the primary endpoint.

Participants needed: 28
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Second Affiliated Hospital, School of Medicine, Zhejiang UniversityUpdated: Nov 8, 2022Locations: 1
Eligibility criteria

Histologically confirmed Primary Central Nervous System (CNS) lymphoma Age range... [+11]

Patient with systemic, non-CNS lymphoma metastatic to the CNS. [+17]

Status: Not yet recruiting

Penpulimab Combined With RMA Treatment of Primary Diagnosis of Primary Central Nervous System Lymphoma

To explore PFS, ORR (CR/CRu+PR), OS and side effects of piamprizumab combined with RMA in newly diagnosed PCNSL, so as to clarify the value of piamprizumab combined with RMA in the first-line treatment of PCNSL patients, and to clarify the clinical and biological factors affecting the efficacy

Participants needed: 23
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: The First Affiliated Hospital with Nanjing Medical UniversityUpdated: Apr 26, 2022
Eligibility criteria

For initial PCNSL confirmed by pathological tissue, the diagnostic criteria were... [+2]

Organs or lymph nodes outside the central nervous system are involved [+5]

Status: Recruiting

Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With PCNSL

This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in elderly patients with primary central nervous system lymphoma (PCNSL).

Participants needed: 100
Trial details
Phase: Phase 2, Phase 3Age: 60-75Biological sex: AllType: InterventionalSponsor: Navy General Hospital, BeijingUpdated: Sep 9, 2020Locations: 1
Eligibility criteria

Newly diagnosed histologically proven non-Hodgkin's lymphoma (NHL).

Involved sites other than the brain, meninges, CSF, or the eyes. [+9]

Status: Recruiting

Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy

This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in primary central nervous system lymphoma (PCNSL) patients.

Participants needed: 100
Trial details
Phase: Phase 2, Phase 3Age: 18-75Biological sex: AllType: InterventionalSponsor: Navy General Hospital, BeijingUpdated: Sep 9, 2020Locations: 1
Eligibility criteria

Newly diagnosed histologically proven non-Hodgkin's lymphoma (NHL).

Involved sites other than the brain, meninges, CSF, or the eyes. [+9]