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A multicenter, phase II, prospective study of orelabrutinib combined with rituximab and methotrexate regimen in untreated primary central nervous system lymphoma

A multicenter, phase II, prospective study of orelabrutinib combined with rituximab and methotrexate regimen in untreated primary central nervous system lymphoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049862
Enrollment
Unknown
Registered
2021-08-10
Start date
2021-08-11
Completion date
Unknown
Last updated
2022-04-19

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

Experimental group:Orelabrutinib+Rituximab+Methotrexate

Sponsors

Department of lymphoma and plasmacytoma disease,Senior Department of Hematology,the Fifth Medical Center of PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with no previous treatment and pathological diagnosis of primary central diffuse large B-cell lymphoma; 2. Aged 18 to 70 years; 3. Before performing specific operations, sign an informed consent form; 4. At least one measurable lesion; 5. Have adequate organ function, including: blood routine: neutrophils >=1.5x10^9/L, hemoglobin >=80g/L, platelets >=75x10^9/L; total bilirubin 50ml/min; 6. The expected survival period is more than 3 months.

Exclusion criteria

Exclusion criteria: 1. Those who have contraindications to any of the components of the orelabrutinib, rituximab, and methotrexate regimens; 2. History of other malignancies that may affect the compliance of the study protocol or the analysis of the results; 3. Severe cardiac insufficiency; 4. Use other anti-tumor treatments other than this study; 5. Patients known to be HIV-positive; 6. Pregnant or lactating women; 7. There are clinical conditions that other investigators consider unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Overall response rate;Complete response rate;

Secondary

MeasureTime frame
Progression free survival;Overall survival rate;Adverse event;

Countries

China

Contacts

Public ContactHuang Wenrong

Department of lymphoma and plasmacytoma disease,Senior Department of Hematology,the Fifth Medical Center of PLA General Hospital

huangwr301@163.com+86 15010955827

Outcome results

None listed

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