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New treatment option for Primary Central Nervous System Lymphoma
Official title Orelabrutinib,Rituximab and Methotrexate in Newly Diagnosed Primary Central Nervous System Lymphoma
ClinicalTrials.gov ID: NCT05600660
What this study is testing
What is Orelabrutinib?
Orelabrutinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for primary central nervous system lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Histologically confirmed Primary Central Nervous System (CNS) lymphoma Age range 18-75 years old.
- Eastern Cooperative Oncology Group performance status 0 to 3.
- Previously untreated. Patients treated with steroid alone are eligible.
- Measurable disease was defined as at least ≥1.0cm in short-diameter by MRI.
- Life expectancy of ≥ 3 months (in the opinion of the investigator).
You likely can't join if
- Patient with systemic, non-CNS lymphoma metastatic to the CNS.
- Patient is concurrently using other approved or investigational antineoplastic agents.
- Presence of active hepatitis B virus(HBV) infection (HBsAg positive and HBV-DNA≥ 104), hepatitis C virus(HCV) infection, acquired and congenital...
- Patient is allergic to components of the study drug.
- Patient has an active concurrent malignancy requiring active therapy.
- Patient has significant abnormalities on screening electrocardiogram (EKG) and active and significant cardiovascular disease such as uncontrolled or...
See the full eligibility criteria
- Histologically confirmed Primary Central Nervous System (CNS) lymphoma Age range 18-75 years old.
- Eastern Cooperative Oncology Group performance status 0 to 3.
- Previously untreated. Patients treated with steroid alone are eligible.
- Measurable disease was defined as at least ≥1.0cm in short-diameter by MRI.
- Life expectancy of ≥ 3 months (in the opinion of the investigator).
- Participants must be able to understand and be willing to sign a written informed consent document.
- Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 6 months after the last dose of the study drug. Men who are sexually active must agree to...
- Adequate renal function: Estimated glomerular filtration rate (GFR) or estimated creatinine clearance (CrCl) ≥ 50 mL/min;Serum creatinine ≤ 2 times the upper limit of normal.
- Adequate liver functions: Transaminase (AST/ALT) \< 3 X upper normal value \& Bilirubin \< 2 X upper normal value.
- Adequate hematological function: hemoglobin ≥ 9 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL.
- Must be able to tolerate lumbar puncture and MRI/CT.
- Ability to swallow oral medications.
- Patient with systemic, non-CNS lymphoma metastatic to the CNS.
- Patient is concurrently using other approved or investigational antineoplastic agents.
- Presence of active hepatitis B virus(HBV) infection (HBsAg positive and HBV-DNA≥ 104), hepatitis C virus(HCV) infection, acquired and congenital immunodeficiency diseases include but not limited to HIV.
- Patient is allergic to components of the study drug.
- Patient has an active concurrent malignancy requiring active therapy.
- Patient has significant abnormalities on screening electrocardiogram (EKG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, uncontrolled congestive heart failure...
- Patient is known to have an uncontrolled active systemic infection.
- Patient has a life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety or put the study outcomes at undue risk.
- Women who are pregnant or nursing (lactating), where pregnancy is defined as a state of a female after conception until the termination of gestation, confirmed by a positive plasma human chorionic gonadotropin(hCG)...
- The patient is unwell or unable to participate in all required study evaluations and procedures.
- Drug abuse, medical, psychological or social conditions which may interfering with people' participation in the study or evaluation of the results.
- History of intracranial hemorrhage or clinically significant stroke within 6 months prior to first day of study treatment
- History of significant gastrointestinal disease that would limit absorption of oral medications.
- Warfarin or any other Coumadin-derivative anticoagulant or vitamin K antagonists. Patients must be off warfarin-derivative anticoagulants for at least seven days prior to starting the study drug. Use of low molecular...
- Concurrent use of a moderate or strong inhibitor or inducer of the P450 isoenzyme CYP3A. Participants must be off P450/CYP3A inhibitors and inducers prior to starting the study drug.
- Known bleeding diathesis (e.g. von Willebrand's disease), hemophilia, or active bleeding.
- History of invasive fungal infection, including invasive aspergillosis, or known active tuberculosis.
- Patients considered unsuitable to participate in the study by the researchers.
The study team makes the final eligibility decision.
Where it's taking place
- Hanzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hanzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.