Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT05549284

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

Led by Affiliated Hospital to Academy of Military Medical Sciences · Updated on 2022-09-22

36

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary central nervous system diffuse large B-cell lymphoma confirmed by brain biopsy
  • Age between 18 and 70 years
  • Signed informed consent
  • At least one measurable lesion
  • Neutrophil count ≥1.5 x 10^9/L, hemoglobin ≥80 g/L, platelets ≥75 x 10^9/L, bilirubin less than 2 times upper limit of normal, ALT less than 4 times upper limit of normal, AST less than 4 times upper limit of normal
  • Expected survival time of at least 3 months
Not Eligible

You will not qualify if you...

  • Contraindications to any of the components in Orelabrutinib, Rituximab, or high-dose Methotrexate
  • History of other cancers that might affect study compliance or result analysis
  • Severe heart failure
  • Previous antitumor treatments
  • Positive for HIV antibody
  • Pregnant or breastfeeding women
  • Considered unsuitable for enrollment by researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital 307

Beijing, Beijing Municipality, China, 100071

Actively Recruiting

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Research Team

W

wenrong huang, Dr

CONTACT

S

shihua zhao, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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