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R-MA-PD-1 Versus R-MA in Treatment-naive Primary CNS Lymphoma

ConditionsPrimary Central Nervous System LymphomaDiffuse Large B-Cell 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Penpulimab

    Biological/Vaccine

    Anti-PD-1 monoclonal antibody, 200 mg intravenously on Day 5 of each induction cycle; continued as maintenance in responders.

  • Rituximab

    Drug

    375 mg/m2 intravenously on Day 0 of each induction cycle.

  • Methotrexate

    Drug

    3.5 g/m2 intravenously on Day 1 of each induction cycle.

  • Cytarabine

    Drug

    Age \<60 or ECOG ≤2: 2 g/m2 q12h on Days 2-3; age ≥60 or ECOG \>2: 1 g/m2 q12h on Day 2 (from cycle 2).

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: R-MA-PD-1 (Experimental)Experimental treatment 4 interventions
Group B: R-MA (Active Comparator)Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

2-year progression-free survival (PFS) rate

PFS is defined as the time from randomization to first documented disease progression or relapse (per 2014 Lugano response criteria) or death from any cause, whichever occurs first, as determined by the investigator.

Time frame
2 years from randomization

Secondary outcomes

1

Complete response (CR) rate

Proportion of patients with best overall response of CR by PET-CT during induction, per 2014 Lugano criteria.

Time frame
From randomization through end of induction (6 cycles of 21 days each; up to 18 weeks)
2

Objective response rate (ORR)

Proportion of patients with best overall response of PR or CR during induction, per 2014 Lugano criteria.

Time frame
From randomization through end of induction (6 cycles of 21 days each; up to 18 weeks)
3

Overall survival (OS)

Time from randomization to death from any cause.

Time frame
Up to 3 years from randomization
4

Duration of response (DOR)

Time from first documented response to disease progression or death from any cause.

Time frame
Up to 3 years from randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

WEI XU

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: