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
Sponsored by
About this trial
This is an interventional treatment trial for Primary Central Nervous System Lymphoma
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
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 Patients who did not achieve partial response (PR) were withdrawn, and patients who achieved PR or complete response (CR)/uncertain CR (CRu) were given 3 courses of treatment.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
No
Studies a U.S. FDA-regulated Device Product
No
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
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.
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
No
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
Email
xuwei10000@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
haorui shen
Email
0401shenhaorui@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Penpulimab Combined With RMA Treatment of Primary Diagnosis of Primary Central Nervous System Lymphoma
We'll reach out to this number within 24 hrs