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

  • STATUS
    Recruiting
  • End date
    Dec 21, 2026
  • participants needed
    30
  • sponsor
    Henan Cancer Hospital
Updated on 26 March 2022

Summary

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.

Details
Condition Central Nervous System Lymphoma
Treatment Pemetrexed, ICP-022
Clinical Study IdentifierNCT05209620
SponsorHenan Cancer Hospital
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age between 18 to 75 years old (including 18 and 75)
Diagnosed as diffuse large B-cell lymphoma; Recurrence or progression of central nervous system disease confirmed by imaging ± tissue biopsy pathology or cerebrospinal fluid flow cytometry; Secondary central nervous system lymphoma can also be admitted when the systemic disease is well controlled
Having at least one measurable lesions
World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 ( ECOG 3 due to tumors can be included after being fully assessed by the investigator)
Life expectancy no less than 1 month
enough main organ function
Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
Agreeing to sign the written informed consents

Exclusion Criteria

Poor peripheral disease control of secondary central nervous system lymphoma
Patients used pemetrexed or orelabrutinib in the past
Active malignant tumor need be treated at the same time
Other malignant tumor history
Serious surgery and trauma less than two weeks
Patients with active tuberculosis
Systemic therapy for serious acute/chronic infection
Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
HIV-positive, AIDS patients and untreated active hepatitis
Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
Patients with a history of mental illness or drug abuse
Poor compliance during the trial and/or follow-up phase
Allergies or people who are known to be allergic to any active ingredients, excipients, mouse-derived products or heterologous protein contained in this trial
Researchers determine unsuited to participate in this trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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