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

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)

Sponsors

Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Source 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.

Overall Status Recruiting
Start Date 2022-06-01
Completion Date 2026-05-30
Primary Completion Date 2023-05-30
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
primary endpoint Enrollment is expected to last for two year, followed up for five years
Secondary Outcome
Measure Time Frame
secondary endpoints Enrollment is expected to last for two year, followed up for five years
Enrollment 36
Condition
Intervention

Intervention Type: Drug

Intervention Name: Orelabrutinib,Rituximab and Methotrexate

Description: 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.

Arm Group Label: Orelabrutinib,Rituximab and Methotrexate

Other Name: RMO

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

70 Years

Healthy Volunteers:

No

Overall Contact

Last Name: wenrong huang, Dr

Phone: 861066947177

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Hospital 307 Wenrong Huang, Dr. 861066947169 [email protected]
Location Countries

China

Verification Date

2022-09-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Orelabrutinib,Rituximab and Methotrexate

Type: Experimental

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

Acronym RMO
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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