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Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed PCNSL

StatusRecruiting
PhasePhase 2/3
Started
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Record History

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  1. Recruitment opened
    • Trial sites expanded: 2 → 15 locations
    • Study sites revised (15)
    • Collaborators revised (14)
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 2 to 15
    • Study description shortened, about 14 words
    • Collaborators expanded, about 61 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07185373
Lead Sponsor Huashan Hospital
Collaborators: Qilu Hospital of Shandong University, Xuanwu Hospital, Beijing, The First Affiliated Hospital of Nanchang University, Shanghai Tongji Hospital, Tongji University School of Medicine, Huaxi Hospital, WuhanUnionHospital, Tang-Du Hospital, The Tumor Hospital of Jiangsu Province, Changhai Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, RenJi Hospital, Henan Cancer Hospital, First Affiliated Hospital of Fujian Medical University, Peking University Third Hospital
Conditions
(from sponsor)		 Primary Central Nervous System Lymphoma
Enrollment 215 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov