A Prospective Clinical Study of BTK Inhibitor PD-1 and Formustine in the First-line Treatment of Primary Central Nervous System Lymphoma

  • End date
    Sep 15, 2024
  • participants needed
  • sponsor
    Mingzhi Zhang
Updated on 15 April 2021


To observe the efficacy and safety of a new generation of BTK inhibitor Orelabrutinib combined with PD-1 and fotemustine in the treatment of patients with primary central nervous system lymphoma (PCNSL).


This is an open, one-arm, prospective clinical collaborative study to observe the combined treatment plan of Orelabrutinib combined with PD-1 and fotemustine in newly treated patients with primary central nervous system lymphoma (PCNSL) efficacy and safety.A total of 40 patients plan to participate in the study. The primary endpoints were complete remission rateCRR , and secondary endpoints including objective response rate (ORR)disease control rate(DCR) progression-free survival (PFS) overall survival (OS), and adverse events(ADR).

Condition Primary Central Nervous System Lymphoma, Central Nervous System Lymphoma, Primary CNS Lymphoma, cns lymphoma
Treatment Orelabrutinib combined with PD-1 and fotemustine
Clinical Study IdentifierNCT04831658
SponsorMingzhi Zhang
Last Modified on15 April 2021


Yes No Not Sure

Inclusion Criteria

Age 18-69 years; KPS score 60 points or ECOG score 2 points; expected survival time of more than 3 months; PCNSL confirmed pathologically by tissue biopsy (limited to the brain, not accompanied by lymphoma in other parts of the body) , And histopathological type is diffuse large B-cell lymphoma; no chemotherapy contraindications (blood picture and physiological examination result time <7 days); at least one measurable lesion according to RECIST standards; no other serious diseases that conflict with this plan ; Follow-up is possible; other anti-tumor drugs are not used during this treatment period, and bisphosphonate anti-bone metastasis therapy and other symptomatic treatments can be applied; understand the situation of this study and sign the informed consent

Exclusion Criteria

Those who are currently receiving other chemical, radiotherapy and targeted therapies (received chemotherapy within 3 weeks, received radiotherapy within 2 weeks, or have not recovered from the acute toxicity of any previous treatment); pregnant or lactating women; yes Any uncontrollable medical disease (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction, and interstitial pneumonia, etc.); those who are contraindicated with chemotherapy such as cachexia; have had other malignant tumors in the past Those who have uncontrolled infections; those who have a history of uncontrollable mental illness; those who are considered unsuitable to participate in this trial by the investigator
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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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