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New treatment option for Primary Central Nervous System Lymphoma (PCNSL)
Official title PD-1 Inhibitor Combined With Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) for Newly Diagnosed PCNSL and SCNSL.
ClinicalTrials.gov ID: NCT07410520
What this study is testing
What is PD -1/PD-L1 monoclonal antibody?
PD -1/PD-L1 monoclonal antibody is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for primary central nervous system lymphoma (pcnsl).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, open-label, single-arm, prospective clinical study of PD-1 inhibitor combined with rituximab, methotrexate, and orelabrutinib (PD-1i+RMO) in the treatment of newly diagnosed primary central nervous system lymphoma (ND-PCNSL) and secondary central nervous system lymphoma (SCNSL). The primary endpoint is 1-year progression-free survival (PFS).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- [1] Newly diagnosed PCNSL confirmed by histopathology, or independently relapsed SCNSL (diffuse large B-cell lymphoma), diagnosed according to the...
- Hematology: Absolute neutrophil count (ANC) ≥ 1.0×10⁹/L, platelet count (PLT) ≥ 50×10⁹/L, hemoglobin (HGB) ≥ 8.0 g/dL; no administration of...
- Liver function: Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST)...
- Renal function: Serum creatinine (Cr) ≤ 1 × ULN or creatinine clearance (CCr) ≥ 90 mL/min.
- Cardiac function: Cardiac function class below Grade III (NYHA criteria); echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%.
You likely can't join if
- Presence of disease involvement outside the central nervous system.
- History of a second primary malignancy (except for adequately treated non-melanoma skin cancer, superficial bladder cancer, carcinoma in situ of the...
- History of allergic disease, severe drug allergy, or known hypersensitivity to macromolecular protein preparations or any component of the PD-1...
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or CAR-T cell therapy (or any other antibody targeting T-cell...
- Previous allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Planned to receive other systemic anti-tumor therapies during the study period.
See the full eligibility criteria
- [1] Newly diagnosed PCNSL confirmed by histopathology, or independently relapsed SCNSL (diffuse large B-cell lymphoma), diagnosed according to the 2016 WHO diagnostic criteria. [2] Signed written informed consent, and...
- Hematology: Absolute neutrophil count (ANC) ≥ 1.0×10⁹/L, platelet count (PLT) ≥ 50×10⁹/L, hemoglobin (HGB) ≥ 8.0 g/dL; no administration of granulocyte growth factors, platelet transfusion, or red blood cell transfusion...
- Liver function: Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.
- Renal function: Serum creatinine (Cr) ≤ 1 × ULN or creatinine clearance (CCr) ≥ 90 mL/min.
- Cardiac function: Cardiac function class below Grade III (NYHA criteria); echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%.
- Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ ULN + 10 s, and prothrombin time (PT) ≤ ULN + 3 s.
- Thyroid function: Baseline thyroid-stimulating hormone (TSH) level within normal range, or abnormal baseline TSH with normal T3/T4 and no associated symptoms. [6] Life expectancy \> 3 months. [7] Age ≥ 18 years. [8]...
- Presence of disease involvement outside the central nervous system.
- History of a second primary malignancy (except for adequately treated non-melanoma skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, intramucosal carcinoma of the gastrointestinal tract, or...
- History of allergic disease, severe drug allergy, or known hypersensitivity to macromolecular protein preparations or any component of the PD-1 monoclonal antibody injection formulation.
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or CAR-T cell therapy (or any other antibody targeting T-cell co-stimulation or checkpoint pathways).
- Previous allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Planned to receive other systemic anti-tumor therapies during the study period.
- Use of anti-cancer vaccines or other immunostimulatory anti-tumor therapy within 3 months before the first dose.
- Severe acute or chronic infection requiring systemic therapy.
- Active, known, or suspected autoimmune disease (refer to Appendix 5), or history of such disease within the past 2 years (patients with vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic treatment...
- Use of immunosuppressive drugs within 4 weeks prior to the first study treatment, excluding intranasal, inhaled, or other local glucocorticoids or physiologic doses of systemic glucocorticoids (i.e., no more than 10...
- Positive human immunodeficiency virus antibody (HIV-Ab), active hepatitis, or other uncontrolled infectious diseases.
- Current or previous history of idiopathic pulmonary fibrosis or idiopathic pneumonia.
- Known active tuberculosis.
- Previous history of grade ≥3 immune-related adverse events from prior immunotherapy.
- History of definite neurological or psychiatric disorders.
- Administration of any live vaccine against infectious diseases within 4 weeks before the first dose or planned use during the study period (e.g., influenza vaccine, chickenpox vaccine, etc.).
- Clear history of alcohol or drug abuse.
- Pregnancy or lactation.
- Participation in other investigational drug studies with active treatment within 1 month before the first dose.
- Any other condition that, in the investigator's judgment, may affect the evaluation of how well it works or safety in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.