Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05209620

Orelabrutinib Combined With Pemetrexed For Relapsed/Refractory Central Nervous System Lymphoma

Led by Henan Cancer Hospital · Updated on 2025-04-23

30

Participants Needed

1

Research Sites

260 weeks

Total Duration

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AI-Summary

What this Trial Is About

This is a prospective single arm, phase II clinical trial to observe the efficacy and safety of orelabrutinib combined with pemetrexed in the treatment for patients with relapsed/refractory central nervous system lymphoma.

CONDITIONS

Official Title

Orelabrutinib Combined With Pemetrexed For Relapsed/Refractory Central Nervous System Lymphoma

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 to 75 years old (including 18 and 75)
  • Diagnosed as diffuse large B-cell lymphoma with recurrence or progression of central nervous system disease confirmed by imaging, tissue biopsy pathology, or cerebrospinal fluid flow cytometry
  • Secondary central nervous system lymphoma allowed if systemic disease is well controlled
  • At least one measurable lesion
  • ECOG performance status 0-2 (ECOG 3 due to tumors may be included after full assessment)
  • Life expectancy of at least 1 month
  • Adequate main organ function
  • Negative pregnancy test within 7 days for women of childbearing potential, with contraception during study and for 6 months after
  • Signed written informed consent
Not Eligible

You will not qualify if you...

  • Poor peripheral disease control of secondary central nervous system lymphoma
  • Prior use of pemetrexed or orelabrutinib
  • Active malignant tumor requiring treatment
  • History of other malignant tumors
  • Serious surgery or trauma within 2 weeks
  • Active tuberculosis
  • Serious acute or chronic infection requiring systemic therapy
  • Congestive heart failure, uncontrolled coronary disease, arrhythmia, or heart infarction within 6 months
  • HIV-positive, AIDS, or untreated active hepatitis
  • History of deep vein thrombosis or pulmonary embolism within 12 months
  • History of mental illness or drug abuse
  • Poor compliance during trial or follow-up
  • Allergies to active ingredients, excipients, mouse-derived products, or heterologous proteins in the trial
  • Investigator determines participant is unsuitable for the trial

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

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

Actively Recruiting

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Research Team

Z

Zhihua Yao, M.D. Ph.D

CONTACT

Y

Yanyan Liu, M.D. Ph.D

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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