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

Sponsor
The First Affiliated Hospital with Nanjing Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05347641
Collaborator
(none)
23
Enrollment
1
Arm
84
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: Penpulimab combined with RMA was used for first-line treatment of PCNSL

One course of treatment was performed every 21 days. After 3 courses, patients underwent cranial MR+ whole-body enhanced CT for disease assessment. Patients who did not achieve partial response (PR) were withdrawn, and patients who achieved PR or complete response (CR)/uncertain CR (CRu) were given 3 courses of treatment.

Drug: Penpulimab
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

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • The First Affiliated Hospital with Nanjing Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The First Affiliated Hospital with Nanjing Medical University
    ClinicalTrials.gov Identifier:
    NCT05347641
    Other Study ID Numbers:
    • IRB-GL1-AF03
    First Posted:
    Apr 26, 2022
    Last Update Posted:
    Apr 26, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Cytarabine
    Methotrexate

    Study Results

    No Results Posted as of Apr 26, 2022