Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed PCNSL
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHuashan Hospital
About this trial
This is a three-arm, multicenter, randomized controlled trial. Eligible participants will be randomized to one of three induction regimens via stratified block randomization at a 2:2:1 ratio.
Induction regimens:
Arm A: Teniposide + orelabrutinib + rituximab + methotrexate (MTX) + dexamethasone, administered in 21-day cycles.
Arm B: Orelabrutinib + rituximab + MTX + dexamethasone, administered in 21-day cycles.
Arm C: Rituximab + MTX + dexamethasone, administered in 21-day cycles. Participants achieving complete response (CR) or unconfirmed complete response (CRu) post-induction will proceed to consolidation therapy, with options including: MTX + rituximab (once every 3 months for 1 year); high-dose chemotherapy followed by autologous stem cell transplantation (ASCT); dose-reduced whole brain radiotherapy; or other modalities (as determined by the investigator).
Eligibility criteria
Qualifiers
No prior systemic treatment for primary central nervous system lymphoma
Pathologically confirmed as diffuse large B-cell lymphoma subtype; with sufficient residual surgical specimens remaining after meeting the needs for pathological diagnosis and preservation
Aged 18-75 years (inclusive)
ECOG performance status ≤3
Disqualifiers
Lymphoma involving sites outside the central nervous system (CNS)
Patients with a previous history of tumors
Patients with intraocular lymphoma or suspected diagnosis of intraocular lymphoma invasion
New York Heart Association (NYHA) class Ⅲ-Ⅳ congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first administration of study drugs; clinically significant or treatment-requiring arrhythmias at screening; left ventricular ejection fraction (LVEF) <50%; or patients with controlled coronary heart disease who are either not using anticoagulants/antiplatelet drugs or taking 2 or more anticoagulants/antiplatelet drugs orally.
Trial design
Treatments tested in this trial
- Teniposide
- Orelabrutinib
- MTX
- Rituximab (R)
- Dexamethasone
Treatment groups
215 Participants
are divided into 3 treatment groupsSponsors and collaborators
Huashan Hospital
Lead sponsor
Qilu Hospital of Shandong University
Collaborator
Xuanwu Hospital, Beijing
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Shanghai Tongji Hospital, Tongji University School of Medicine
Collaborator
Huaxi Hospital
Collaborator
WuhanUnionHospital
Collaborator
Tang-Du Hospital
Collaborator
The Tumor Hospital of Jiangsu Province
Collaborator
Changhai Hospital
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
RenJi Hospital
Collaborator
Henan Cancer Hospital
Collaborator
First Affiliated Hospital of Fujian Medical University
Collaborator
Peking University Third Hospital
Collaborator
Source ClinicalTrials.gov