Actively Recruiting
Orelabrutinib,Rituximab and Methotrexate in Newly Diagnosed Primary Central Nervous System Lymphoma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2022-11-08
28
Participants Needed
1
Research Sites
282 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
It is a single arm, multicenter, phase 2 study to explore the efficacy and safety study of OR-MTX chemotherapy（Orelabrutinib, Rituximab and Methotrexate）as first-line regimens in the treatment of newly diagnosed primary central nervous system lymphoma. Objective response rate is the primary endpoint.
CONDITIONS
Official Title
Orelabrutinib,Rituximab and Methotrexate in Newly Diagnosed Primary Central Nervous System Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed primary central nervous system lymphoma
- Age between 18 and 75 years old
- Eastern Cooperative Oncology Group performance status between 0 and 3
- Previously untreated, except treatment with steroids alone is allowed
- Measurable disease of at least 1.0 cm in short diameter by MRI
- Life expectancy of at least 3 months as judged by the investigator
- Able to understand and willing to sign informed consent
- Women of reproductive potential must agree to use effective birth control during therapy and for 6 months after last dose
- Men who are sexually active must agree to use effective contraception during therapy and for 6 months after last dose
- Negative plasma pregnancy test for women of childbearing potential at study entry
- Adequate kidney function: estimated glomerular filtration rate or creatinine clearance of 50 mL/min or higher; serum creatinine no more than twice the upper limit of normal
- Adequate liver function: transaminases (AST/ALT) less than 3 times upper normal value; bilirubin less than 2 times upper normal value
- Adequate blood counts: hemoglobin 9 g/dL or higher, absolute neutrophil count 1,500/µL or higher, platelet count 75,000/µL or higher
- Able to tolerate lumbar puncture and MRI or CT scans
- Able to swallow oral medications
You will not qualify if you...
- Systemic non-CNS lymphoma that has spread to the CNS
- Concurrent use of other approved or investigational anti-cancer agents
- Active hepatitis B infection (HBsAg positive and HBV-DNA ≥ 10⁴), hepatitis C infection, or immunodeficiency diseases including HIV
- Allergy to any component of the study drugs
- Active cancer requiring treatment other than primary CNS lymphoma
- Significant abnormal electrocardiogram or serious cardiovascular disease such as uncontrolled arrhythmias, congestive heart failure, hypertension, valvular disease, pericarditis, or recent heart attack within 6 months
- Known uncontrolled active systemic infection
- Life-threatening illness or organ dysfunction that could affect safety or study outcomes
- Pregnant or nursing women
- Unable to participate in all required study procedures and evaluations
- Drug abuse or medical, psychological, or social conditions interfering with study participation or assessment
- History of intracranial hemorrhage or significant stroke within 6 months before starting study treatment
- Significant gastrointestinal disease affecting oral medication absorption
- Use of warfarin or vitamin K antagonists without stopping at least 7 days before study drug; low molecular weight heparin and novel oral anticoagulants allowed
- Use of moderate or strong CYP3A enzyme inhibitors or inducers before starting study drug
- Known bleeding disorders or active bleeding
- History of invasive fungal infection or active tuberculosis
- Considered unsuitable for study participation by researchers
AI-Screening
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Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hanzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
W
Wenbin Qian, prof.
CONTACT
X
Xianggui Yuan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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