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

NCT05347641 | Not Yet Recruiting Phase 2

• 1 other identifier: IRB-GL1-AF03
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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

Conditions

Primary Central Nervous System Lymphoma

Outcome Measures

Primary Outcomes (1)

• 2-year PFS rate of PCNSL patients treated with penpulimab combined with RMA

  2 years

Secondary Outcomes (1)

• ORR, 2-year OS rate and safety of penpurlimab combined with RMA in first-line treatment of PCNSL patients

  2 years

Study Arms (1)

Penpulimab combined with RMA was used for first-line treatment of PCNSL

EXPERIMENTAL

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 Patients who did not achieve partial response (PR) were withdrawn, and patients who achieved PR or complete response (CR)/uncertain CR (CRu) were given 3 courses of treatment.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

Interventions

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

Also known as: rituximab, Methotrexate, Cytarabine

Penpulimab combined with RMA was used for first-line treatment of PCNSL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Interventions

penpulimab; Rituximab; Methotrexate; Cytarabine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

wei M xu

CONTACT

02568306034; xuwei10000@hotmail.com

haorui shen

CONTACT

0401shenhaorui@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 26, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share