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Clinical application of orelabrutinib targeted therapy in induction and maintenance therapy of primary central nervous system diffuse large B-cell lymphoma

Clinical application of orelabrutinib targeted therapy in induction and maintenance therapy of primary central nervous system diffuse large B-cell lymphoma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052815
Enrollment
Unknown
Registered
2021-11-05
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-08-16

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

Sponsors

Xinqiao Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Diffuse large B-cell lymphoma originating in the brain, spinal cord, eye or pia mater without evidence of systemic involvement; 2. Aged 18-70 years (including 18 and 70 years), gender is not limited; 3. ECOG score 2 points due to craniocerebral surgery), and the expected survival period is >= 3 months; 4. No previous history of malignant tumor; no other tumors requiring active treatment with an overall survival period of less than 5 years; 5. Blood routine test within 14 days before enrollment: Hb >= 85 g/L, ANC >= 1.0 x 10^9/L, PLT >= 80 x 10^9/L; liver and kidney function satisfaction: TBIL <= 1.5 x ULN, ALT, AST<= 2.0 x ULN, Cr <= 1.5 x ULN; 6. Have not received radiotherapy, chemotherapy, targeted therapy or stem cell transplantation within 4 weeks before enrollment; 7. Voluntary subjects and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Received systemic or local therapy such as chemotherapy and/or hematopoietic stem cell transplantation in the past; 2. Chronic or currently active infectious diseases requiring systemic antibiotics, antifungals or antiviral therapy; 3. Patients with severe cardiac insufficiency and cardiac ejection fraction EF less than 50%; or severe arrhythmia, who cannot tolerate chemotherapy as assessed by the investigator; 4. With severe pulmonary insufficiency (obstructive and/or restrictive ventilation disorder), investigators evaluate those who cannot tolerate chemotherapy; 5. Accompanied by severe liver function impairment, liver function indexes (ALT, TBIL) are more than 2 times higher than the upper limit of normal (ULN); 6. With severe renal insufficiency, the renal function index (Cr) is more than 2 times the upper limit of normal value (ULN); or the 24-hour urinary creatinine clearance rate Ccr is lower than 50 ml/min, and the investigator evaluates that the preconditioning regimen cannot be tolerated ; 7. Psychiatric patients or other patients who are known or suspected to be unable to fully comply with the study protocol; 8. Women who are pregnant, planning to become pregnant or breastfeeding; 9. HIV-infected persons; 10. Patients who cannot be guaranteed to complete the necessary treatment plan and follow-up observation.

Design outcomes

Primary

MeasureTime frame
Overall survival;

Secondary

MeasureTime frame
Complete remission;2 year ovarall survival;2 year progression free survival;2 year recurrence/progression;Chemotherapy-related adverse reactions;

Countries

China

Contacts

Public ContactGao Li

Xinqiao Hospitoal, Army Medical University

577162690@qq.com+86 15736263675

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026