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

• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05549284
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 47.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Central Nervous System Lymphoma	Drug: Orelabrutinib,Rituximab and Methotrexate	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: May 30, 2023
• Anticipated Study Completion Date: May 30, 2026

Arms and Interventions

Arm

Intervention/Treatment

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

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.; Other Names: RMO

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital 307	Beijing	Beijing	China	100071

Sponsors and Collaborators

• Affiliated Hospital to Academy of Military Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Affiliated Hospital to Academy of Military Medical Sciences
• ClinicalTrials.gov Identifier: NCT05549284
• Other Study ID Numbers: 307-947168-88
• First Posted: Sep 22, 2022
• Last Update Posted: Sep 22, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Lymphoma; Rituximab; Methotrexate

Study Results

No Results Posted as of Sep 22, 2022