Overview

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

Status:
Not yet recruiting
Trial end date:
2029-06-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Treatments:
Cytarabine
Methotrexate
Criteria
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