A Phase 2 interventional study of Orelabrutinib,Rituximab and Methotrexate in Primary Central Nervous System Lymphoma, sponsored by Affiliated Hospital to Academy of Military Medical Sciences. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-09-22.
Sponsored by Affiliated Hospital to Academy of Military Medical Sciences · Phase 2, Interventional, and Treatment
This is a prospective single arm,multi-center,phase 2 study,and this study is to evaluate the efficacy and safety of Orelabrutinib,Rituximab combined with high-dose Methotrexate(RMO) as first line regimens in the treatments of newly diagnosed primary central nervous system lymphoma(PCNSL).Objective response and complete response are the primary endpoint.
This is a single-arm,multicenter,phase 2 study to evaluate the efficacy and safety of Orelabrutinib,Rituximab combined with high-dose Methotrexate(RMO) as first line regimens in the treatments of newly diagnosed primary central nervous system lymphoma.The response will be evaluated every 2 cycles.Patients who achieved complete remission(CR) or partial remission(PR) will receive further treatment,and there are 6 cycles of RMO regimen for the induction.The patients with stable disease(SD) or progressed disease(PD) will withdraw from the trial and receive salvage regimens.After total 6 induction cycles,the investigators evaluate the efficiency again.After 6 cycles,the patients who receive CR or PR,can tolerate Autologous Hematopoietic Stem Cell Transplantation(AHSCT) will be candidates of high-dose chemotherapy and stem rescue.The patients who achieve CR or PR,cannot tolerate AHSCT will go to whole brain radiotherapy or Orelabrutinib maintenance.The patients with SD or PD will receive salvage regimen.
Affiliated Hospital to Academy of Military Medical Sciences is the lead sponsor of 66 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Rituximab 375 mg/m2 d1; MTX 3.5mg/m2,d2; Orelabrutinib 150g/day; every three week/cycle.
Drug: Orelabrutinib,Rituximab and Methotrexate
Drug pages: Orelabrutinib · Rituximab · Methotrexate
Orelabrutinib, Rituximab combined with high-dose Methotrexate(RMO) as first line regimens in the treatments of newly diagnosed primary central nervous system lymphoma. The response will be evaluated every 2 cycles. Patients who achieved complete remission (CR) or partial remission (PR) will receive further treatment, and there are 6 cycles of RMO regimen for the induction. The patients with stable disease (SD) or progressed disease(PD) will withdraw from the trial and receive salvage regimens. After total 6 induction cycles, the investigators evaluate the efficiency again. After 6 cycles, the patients who receive CR or PR, can tolerate Autologous Hematopoietic Stem Cell Transplantation (AHSCT) will be candidates of high-dose chemotherapy and stem rescue. The patients who achieve CR or PR, cannot tolerate AHSCT will go to whole brain radiotherapy or Orelabrutinib maintenance. The patients with SD or PD will receive salvage regimen.
Also known as: RMO
primary endpoint
Objective response rate(ORR) is the primary endpoint
Time frame: Enrollment is expected to last for two year, followed up for five years
secondary endpoints
Complete rate(CR)、progression free survival(PFS)、overall survival(OS) are the secondary endpoints
Time frame: Enrollment is expected to last for two year, followed up for five years
Plan to share: No
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This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Orelabrutinib · Rituximab · Methotrexate
Affiliated Hospital to Academy of Military Medical Sciences