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

NCT05549284 | Recruiting Phase 2

• 1 other identifier: 307-947168-88
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Central Nervous System Lymphoma

Outcome Measures

Primary Outcomes (1)

• primary endpoint

  Objective response rate(ORR) is the primary endpoint

  Enrollment is expected to last for two year, followed up for five years

Secondary Outcomes (1)

• secondary endpoints

  Enrollment is expected to last for two year, followed up for five years

Study Arms (1)

Orelabrutinib,Rituximab and Methotrexate

EXPERIMENTAL

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

Drug: Orelabrutinib,Rituximab and Methotrexate

Interventions

Orelabrutinib,Rituximab and Methotrexate DRUG

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

Orelabrutinib,Rituximab and Methotrexate

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital to Academy of Military Medical Sciences: lead

Study Sites (1)

Hospital 307

Beijing, Beijing Municipality, 100071, China

RECRUITING

MeSH Terms

Interventions

orelabrutinib; Rituximab; Methotrexate

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

wenrong huang, Dr

CONTACT

861066947177; huangwr301@163.com

shihua zhao, Dr

CONTACT

861066947178; zhaoshihua307@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: September 22, 2022
• Study Start: June 1, 2022
• Primary Completion: May 30, 2023
• Study Completion (Estimated): May 30, 2026
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)