RecruitingPhase II/IIIEN original

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the 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).

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek 18-75 lat
  • Chłoniak potwierdził biopsia (typ DLBCL)
  • Brak poprzedniego leczenia tego schorzenia
  • Dobre funkcjonowanie narządów wewnętrznych (wątroba, nerki)
  • Zdolność do tolerowania punkcji plever lub posiadania rezerwuaru Ommaya
  • Brak komórek białaczkowych we krwi obwodowej
  • Oczekiwany czas przeżycia co najmniej 3 miesiące
  • Pisemna zgoda na uczestnictwo w badaniu

✗ Disqualifies

  • Chłoniak rozprzestrzeniający się poza mózg i rdzeń kręgowy
  • Wcześniejsza historia innych nowotworów
  • Chłoniak w oku lub podejrzenie chłoniaka w oku
  • Poważne choroby serca (niewydolność, nieustabilizowana choroba wieńcowa)
  • Niekontrolowane zaburzenia krzepnięcia krwi

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
75 Years
Last updated (source)
August 19, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (15)

Peking University Third Hospital

Beijing, China

Xuanwu Hospital

Beijing, China

Huaxi Hospital

Chengdu, China

First Affiliated Hospital of Fujian Medical University

Fuzhou, China

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, China

Department of Hematology, Qilu Hospital of Shandong University

Jinan, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

The Tumor Hospital of Jiangsu Province

Nanjing, China

Changhai Hospital

Shanghai, China

Huashan Hospital

Shanghai, China

RenJi Hospital

Shanghai, China

Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai, China

WuhanUnionHospital

Wuhan, China

Tang-Du Hospital

Xi'an, China

Henan Cancer Hospital

Zhengzhou, China

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/19/2026.

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