Penpulimab Combined With RMA Treatment of Primary Diagnosis of Primary Central Nervous System Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Penpulimab.
- Who it may be relevant to
- Registry conditions: Primary Central Nervous System Lymphoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- 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
Primary outcome measures
- 2-year PFS rate of PCNSL patients treated with penpulimab combined with RMA [Time frame: 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 [Time frame: 2 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Shen HR, Wu JZ, Yin H, Du KX, Sibusiso L, Wu YF, Hua W, Li Y, Kong YL, Zhang XY, Gao R, Li JY, Wang L, Liang JH, Xu W. Penpulimab combined with rituximab, high-dose methotrexate, and cytarabine (Pen-RMA) in newly diagnosed primary central nervous system lymphoma (PCNSL): a phase 2 trial. Blood Cancer J. 2026 Feb 11;16(1):23. doi: 10.1038/s41408-026-01450-w. PMID 41672977
Identifiers
NCT: NCT05347641 · IRB-GL1-AF03