Status:
NOT_YET_RECRUITING
Penpulimab Combined With RMA Treatment of Primary Diagnosis of Primary Central Nervous System Lymphoma
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Primary Central Nervous System Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 treatmen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05347641
Start Date
June 1 2022
End Date
June 1 2029
Last Update
April 26 2022
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