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

Phase 2

Recruiting

• Conditions: Primary Central Nervous System Lymphoma
• Interventions: Drug: Orelabrutinib,Rituximab and Methotrexate

• Registration Number: NCT05549284
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-08-24
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-19
• Last Update Submitted: 2022-09-19
• Study First Posted: 2022-09-22
• Last Update Posted: 2022-09-22
• Primary Completion: 2023-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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,AST4XULN
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Orelabrutinib,Rituximab and Methotrexate	Orelabrutinib,Rituximab and Methotrexate	Rituximab 375 mg/m2 d1; MTX 3.5mg/m2,d2; Orelabrutinib 150g/day; every three week/cycle.

Primary Outcome Measures

Name	Time	Method
primary endpoint	Enrollment is expected to last for two year, followed up for five years	Objective response rate(ORR) is the primary endpoint

Secondary Outcome Measures

Name	Time	Method
secondary endpoints	Enrollment is expected to last for two year, followed up for five years	Complete rate(CR)、progression free survival(PFS)、overall survival(OS) are the secondary endpoints

Trial Locations

Locations (1)

Hospital 307; 🇨🇳 Beijing, Beijing, China