R-MA-PD-1 Versus R-MA in Treatment-naive Primary CNS Lymphoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWEI XU
About this trial
This is a prospective, open-label, multicenter, randomized controlled study in treatment-naive patients with primary central nervous system lymphoma (PCNSL, DLBCL type). Eligible participants are randomized 1:1 to the experimental arm (R-MA-PD-1: rituximab, methotrexate, cytarabine plus penpulimab) or the control arm (R-MA: rituximab, methotrexate, cytarabine). Induction is administered every 21 days for 6 cycles, followed by risk- and response-adapted consolidation (ASCT or whole-brain radiotherapy) and penpulimab maintenance. The primary objective is to compare the 2-year progression-free survival rate between the two arms.
Eligibility criteria
Qualifiers
Fully understands the study and voluntarily signs informed consent.
Age 18 to 80 years.
Treatment-naive, pathologically (immunophenotypically) confirmed PCNSL (per 2016 WHO classification).
Diffuse large B-cell lymphoma originating in the CNS without other organ involvement, confirmed by PET-CT or contrast-enhanced CT.
Disqualifiers
Contraindication to any study drug.
Clinically significant liver disease, including viral or other hepatitis or cirrhosis (active HBV or active hepatitis C as defined).
HIV infection.
History of allergic disease, severe drug allergy, or known hypersensitivity to macromolecular protein preparations or any component of penpulimab.
Trial design
Treatments tested in this trial
- Penpulimab
- Rituximab
- Methotrexate
- Cytarabine
Treatment groups
58 Participants
are divided into 2 treatment groupsSponsors and collaborators
WEI XU
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Sponsor institution
Source ClinicalTrials.gov