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Clinical trial of ORT combined with/without high-dose MTX regimen in the treatment of primary central nervous system lymphoma

Clinical trial of ORT combined with/without high-dose MTX regimen in the treatment of primary central nervous system lymphoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062302
Enrollment
Unknown
Registered
2022-08-01
Start date
2022-08-10
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Primary central nervous system lymphoma

Interventions

Case series:ORT combined with/without high-dose MTX

Sponsors

The First Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed primary central nervous system B cell lymphoma by pathology; 2. With measurable lesions, brain-enhanced MRI parenchyma lesions (>10*10 mm); only meningeal lesions, require cytological examination of cerebrospinal fluid (CSF) to confirm lymphoma cells; 3. Age >= 18 years old; 4. ECOG 0-3; 5. Obtain the informed consent signed by the patient or his family.

Exclusion criteria

Exclusion criteria: 1. Received systemic or local treatment including chemotherapy in the first three weeks; 2. Liver and kidney function: blood bilirubin > 2mg / dl (35 µ AST / ALT was more than 2 times of the upper limit of normal, serum creatinine was more than 177 µ The creatinine clearance rate was less than 60 ml/min; 3. Normal heart function: EF <= 50%; 4. The expected survival time was less than 3 months; 5. chronic or current active infectious diseases requiring systemic antibiotics, antifungal agents or antiviral therapy; 6. Other concurrent and uncontrollable factors are considered by the researchers to affect the medical status of patients participating in the study. Psychiatric patients or other patients who are known or suspected to be unable to fully comply with the study protocol; 7. People living with HIV.

Design outcomes

Primary

MeasureTime frame
Complete response rate;

Secondary

MeasureTime frame
Overall survival;Objective response rate;Progression free survival;Safety;

Countries

China

Contacts

Public ContactJie Jin/Wenjuan Yu
drwjyu@163.com+86 13505716779

Outcome results

None listed

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