Adding orelabrutinib and teniposide to standard drugs for newly diagnosed brain lymphoma
Official title: Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed PCNSL
Status: Recruiting. It is looking for patients now. Talk to your care team about whether it fits you.
The trial team last updated this record on .
The short version
This study tests whether adding one or two extra drugs to standard treatment helps people newly diagnosed with a lymphoma in the brain.
Read our full plain-language summary
What the trial team says
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).
Key facts
- Registry number
- NCT07185373
- Stage of testing
- Phase 2/Phase 3
- Conditions studied
- Primary Central Nervous System Lymphoma
Where it is running
This trial lists 15 sites.
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China
- Peking University Third Hospital (Beijing)
- Xuanwu Hospital (Beijing)
- Huaxi Hospital (Chengdu)
- First Affiliated Hospital of Fujian Medical University (Fuzhou)
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Guangzhou)
- Department of Hematology, Qilu Hospital of Shandong University (Jinan)
- The First Affiliated Hospital of Nanchang University (Nanchang)
- The Tumor Hospital of Jiangsu Province (Nanjing)
- Changhai Hospital (Shanghai)
- Huashan Hospital (Shanghai)
- RenJi Hospital (Shanghai)
- Shanghai Tongji Hospital, Tongji University School of Medicine (Shanghai)
- and 3 more in China
How to use this
Talk to your care team first. They know your history and can tell you whether this trial is worth your time.
Joining a trial is always your choice. A trial is a test, not a proven treatment. Being in one is not a promise that it will help you.
This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.