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

Primary Purpose

Primary Central Nervous System Lymphoma

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Penpulimab

About this trial

This is an interventional treatment trial for Primary Central Nervous System Lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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 Patients who did not achieve partial response (PR) were withdrawn, and patients who achieved PR or complete response (CR)/uncertain CR (CRu) were given 3 courses of treatment.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05347641

First Posted

April 20, 2022

Last Updated

April 20, 2022

Sponsor

The First Affiliated Hospital with Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05347641

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 1, 2022 (Anticipated)

Primary Completion Date

June 1, 2025 (Anticipated)

Study Completion Date

June 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Central Nervous System Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Penpulimab

Other Intervention Name(s)

rituximab, Methotrexate, Cytarabine

Intervention Description

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 Measure Information:

Title

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

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

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

wei M xu

Phone

02568306034

xuwei10000@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

haorui shen

0401shenhaorui@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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