Orelabrutinib,Rituximab and Methotrexate in Newly-diagnosed Primary Central Nervous System Lymphoma(PCNSL)

Primary Central Nervous System Lymphoma Clinical Trial

— RMO  

Official title:

a Single Arm,Multi-center,Phase II Clinical Trial of Combined Therapy for Orelabrutinib,Rituximab and Methotrexate(RMO)in Newly-diagnosed Primary Center Nervous System Lymphoma(PCNSL)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05549284
• Other study ID #: 307-947168-88
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2022
• Est. completion date: May 30, 2026

Study information

• Verified date: September 2022
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: wenrong huang, Dr
• Phone: 861066947177
• Email: huangwr301[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• primary central nervous system diffuse large B-cell lymphoma histologically confirmed by brain biopsy;

• Aged 18-70 years

• Signature of informed consent;

• At least one measurable lesion;

• Neutropile=1.5X109/L,Hemoglobin=80g/L,Platelets=75X109/L,Billrubin<2XULN,ALT<4XULN,AST 4XULN

• The expected survival time is at least 3 months

Exclusion Criteria:

• Those who have contraindications to any of the components in the Orelabrutinib,Rituximab and HD-MTX

• History of other malignancies that may affect the compliance of the research protocol or the analysis of the results

• Severe cardiac insufficiency

• Other antitumor treatments were used

• Human immunodeficiency virus(HIV)antibody is positive

• Pregnant or lactating women

• Researchers consider if anyone not suitable for enrollment.

Related Conditions & MeSH terms

• Lymphoma
• Primary Central Nervous System Lymphoma

Intervention

Drug:
• Orelabrutinib,Rituximab and 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.

Locations

Country	Name	City	State
China	Hospital 307	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary endpoint	Objective response rate(ORR) is the primary endpoint	Enrollment is expected to last for two year, followed up for five years
Secondary	secondary endpoints	Complete rate(CR)?progression free survival(PFS)?overall survival(OS) are the secondary endpoints	Enrollment is expected to last for two year, followed up for five years