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A multicenter prospective clinical study of zanubrutinib combined with lenalidomide, temozolomide and CD20 mAb ± methotrexate in the treatment of primary / secondary central nervous system diffuse large B-cell lymphoma

A multicenter prospective clinical study of zanubrutinib combined with lenalidomide, temozolomide and CD20 mAb ± methotrexate in the treatment of primary / secondary central nervous system diffuse large B-cell lymphoma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039485
Enrollment
Unknown
Registered
2020-10-29
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-02-01

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

Conditions

central nervous system of Diffuse large B-cell lymphoma

Interventions

A:high-dose MTX and zanubrutini + lenalidomide + temozolomide + CD20 mAb alternately
B:zanubrutini + lenalidomide + temozolomide + CD20 mAb

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. According to the WHO classification of hematopoiesis and lymphoid tissue tumors in 2016, it was confirmed as diffuse large B-cell lymphoma by histological examination, and there was no focus outside the nervous system. 2. Male or female aged 18 or above at the time of signing informed consent. 3. Untreated diffuse large B-cell lymphoma of the central nervous system. 4. Measurable lesions, defined as >= 1 lesion of nervous system with the longest diameter > 1cm, or lymphoma cells in CSF. 5. Normal function of main organs: serum bilirubin = 3 months. 8. Can provide written informed consent, and understand and follow the requirements of the study.

Exclusion criteria

Exclusion criteria: 1. He was diagnosed with other malignant tumors in the previous 12 months; 2. Pregnant or lactating women; 3. Uncontrolled systemic fungal, bacterial, or viral infections (defined as symptoms / signs associated with infection, but not improved despite antibiotic or other treatment); 4. Known or suspected to be related to zebitinib; 5. Known human immunodeficiency virus (HIV) or active viral infection of hepatitis B or C; 6. Have a clear history of neurological or mental disorders, including epilepsy or dementia; 7. According to the judgment of the researcher, there are accompanying diseases that seriously endanger the safety of patients or affect patients to complete the study; 8. Taking other drugs at the same time or participating in clinical trials of other drugs one month before the test.

Design outcomes

Primary

MeasureTime frame
Head MRI;Cerebrospinal fluid flow cytometry;

Secondary

MeasureTime frame
routine blood test;Blood biochemistry;urine routine test;???? Bone marrow puncture;

Countries

China

Contacts

Public ContactRong Fu

Tianjin Medical University General Hospital

florai@sina.com+86 13920350233

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026