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A prospective, single-arm, multicenter clinical study of the chemotherapy regimen (tirelizumab, zebutinib and methotrexate) in treating primary central nervous system diffuse large B cell lymphoma

A prospective, single-arm, multicenter clinical study of the chemotherapy regimen (tirelizumab, zebutinib and methotrexate) in treating primary central nervous system diffuse large B cell lymphoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071346
Enrollment
Unknown
Registered
2023-05-12
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary central nervous system diffuse large B cell lymphoma

Interventions

treatment group:the chemotherapy regimen (tirelizumab, zebutinib and methotrexate)

Sponsors

Shengli Oilfield Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age range = 18 years old, = 80 years old; 2. Primary central nervous system diffuse large B cell lymphoma is verified by histopathology; 3. Brain MRI enhancement scanning must have measurable lesions. No other lesions found on PET/CT or whole body enhanced CT examination; 4. The ECOG physical condition score is 0, 1, or 2 points; 5. During screening, laboratory tests meet the following criteria: (1) Blood routine examination: hemoglobin (Hb) = 90g/L, absolute neutrophil count (ANC) = 1.5 × 109/L, platelet count (PLT) = 90 × 109/L; (2) Biochemical examination: Serum creatinine (Cr) = 1.5 × Upper limit of normal value (ULN); Total bilirubin (TBIL) = 1.5 × ULN; Glutamate transaminase (ALT), cereal grass transaminase (AST) = 2.5 × ULN?

Exclusion criteria

Exclusion criteria: 1. Secondary diffuse large B-cell lymphoma of the central nervous system. 2. Transforming lymphoma, which is derived from other types of lymphoma, such as follicular lymphoma, marginal zone B-cell lymphoma, and chronic lymphocytic leukemia/small B-cell lymphoma; 3. Currently coexisting with other malignant tumors; 4. Participated in other interventional clinical trials within 3 months before the first medication use; 5. There are uncontrollable or important cardiovascular diseases. Having a history of interstitial lung disease (ILD), such as pulmonary fibrosis, or baseline chest CT or MRI showing evidence of ILD; 6. Clinically obvious gastrointestinal abnormalities that may affect drug intake, transport, or absorption (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy; 7. Active infection or active or uncontrolled HBV and HCV infection, HIV/AIDS (Acquired Immune Deficiency Syndrome) or other serious infectious diseases (including active infection refers to infection requiring systemic treatment; HBV/HCV/HIV priority qualitative testing, quantitative testing if necessary; HBV DNA can be included after treatment turns negative); 8. The researcher believes that other situations are not suitable for participating in this experiment.

Design outcomes

Primary

MeasureTime frame
event free survival, EFS;

Secondary

MeasureTime frame
overall response rate, ORR;

Countries

China

Contacts

Public ContactGuoqiang Liu

Shengli Oilfield Central Hospital

26180458@qq.com+86 180 5461 8175

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026