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NCT Number: NCT05347641

Penpulimab Combined With RMA Treatment of Primary Diagnosis of Primary Central Nervous System Lymphoma

To explore PFS, ORR (CR/CRu+PR), OS and side effects of piamprizumab combined with RMA in newly diagnosed PCNSL, so as to clarify the value of piamprizumab combined with RMA in the first-line treatment of PCNSL patients, and to clarify the clinical and biological factors affecting the efficacy

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For initial PCNSL confirmed by pathological tissue, the diagnostic criteria were based on WHO diagnostic criteria in 2016
  • Head MR (plain scan + enhancement) performed 28 days prior to study enrollment should show the presence of at least one measurable lesion in two vertical directions (according to 2014 Lugano criteria); Or abnormal cerebrospinal fluid examination (including cerebrospinal fluid protein, cells, NGS), or ophthalmologic examination confirmed the retina, vitreous lesions
  • PS score was 0~4 according to ECOG

Exclusion criteria

  • Organs or lymph nodes outside the central nervous system are involved
  • Patients with a second primary tumor (other than non-melanoma skin cancer in situ, superficial bladder cancer, cervical cancer in situ, gastrointestinal intramucosal cancer or breast cancer that has been cured and has not recurred within 5 years)
  • Has a history of allergic disease, severe drug allergy, or is known to be allergic to any component of a macromolecular protein preparation or penpulimab injection prescription
  • Prior treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CTLA-4 antibody, or CAR T cell therapy (or any other antibody that acts on T cell co-stimulation or checkpoint pathways)
  • A severe acute or chronic infection requiring systemic treatment
  • The investigator believes that the subjects may have other factors that affect the efficacy or safety evaluation of the study

Treatment and study plan

Penpulimab

Drug

Penpulimab + RMA regimen:

Rituximab 375 mg/m2 d0 iv Methotrexate (MTX) 3.5g/m2 drip D1 Cytarabine * (ARA-C) 1-2g/m2 q12H D2-3 iv Penpulimab 200 mg iv D5

Other names: rituximab, Methotrexate, Cytarabine

Primary outcomes

  1. 2-year PFS rate of PCNSL patients treated with penpulimab combined with RMA

    Time frame: 2 years

Secondary outcomes

  1. ORR, 2-year OS rate and safety of penpurlimab combined with RMA in first-line treatment of PCNSL patients

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

haorui shen

CONTACT

[email protected]

wei M xu

CONTACT

[email protected]

02568306034

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

A Single-arm, Prospective, Single-center, Phase II Clinical Study of Penpulimab Combined With RMA in the Treatment of Newly Diagnosed Primary CNS Lymphoma

Important dates

Study start
2022
Primary completion
2025
Study completion
2029
First posted
Apr 26, 2022
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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