Primary Central Nervous System Lymphoma
Conditions
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
Interventions
DRUGPenpulimab
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
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year PFS rate of PCNSL patients treated with penpulimab combined with RMA | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| ORR, 2-year OS rate and safety of penpurlimab combined with RMA in first-line treatment of PCNSL patients | 2 years |
Contacts
Primary Contactwei M xu
Backup Contacthaorui shen
Outcome results
None listed