Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed PCNSL
Trial statusNot yet recruiting
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
Source ClinicalTrials.gov