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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

23 Participants
are divided into 1 treatment group
Group A: Penpulimab combined with RMA was used for first-line treatment of PCNSLExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: