Actively Recruiting
An Exploratory Study on Camrelizumab (SHR-1210) for Recurrent Primary Central Nervous System Lymphoma (PCNSL)
Led by Beijing Sanbo Brain Hospital · Updated on 2024-10-15
21
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Primary Central Nervous System Lymphoma (PCNSL) is a rare type of non-Hodgkin lymphoma that affects the brain, spinal cord, eyes, and surrounding membranes. Treating recurrent PCNSL is difficult, and there is no standard approach accepted worldwide. This research aims to assess the effectiveness and safety of camrelizumab, a programmed cell death 1 (PD-1) inhibitor, in patients whose PCNSL has returned after initial treatment. Participants will receive camrelizumab (SHR-1210) at a dose of 200 mg every two weeks. Each four-week period counts as one treatment cycle. This phase 2 study explores the impact of camrelizumab on tumor response in patients with recurrent PCNSL. Treatment continues as scheduled, focusing on how well the drug works and its safety profile. During the study, patients will be monitored for their tumor response using MRI scans and assessed for overall health status, side effects, and survival measures. Researchers will track the objective response rate, progression-free survival, overall survival, adverse events, and performance status using the Karnofsky scale over a period of up to three years. Participants will also undergo regular evaluations to ensure ongoing health and safety throughout the study.
CONDITIONS
Brief Title
Camrelizumab for Patients with Recurrent Primary Central Nervous System Lymphoma (PCNSL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed initial diagnosis of primary diffuse large B-cell lymphoma of the central nervous system by histopathology
- Tumor recurrence confirmed by MRI after first-line methotrexate-based treatment
- Measurable tumor focus on MRI larger than 10x10 mm
- Age over 18 years
- Life expectancy of at least 12 weeks
- Karnofsky performance status of at least 50%
- Normal function of main organs without serious blood, heart, lung, liver, kidney, or immune deficiency diseases
- Female participants of childbearing potential must not be pregnant and agree to use effective contraception during the study and for 3 months after treatment
- Understanding of the study purpose and willingness to sign informed consent
You will not qualify if you...
- Receiving any other antitumor therapy concurrently
- Allergy to any ingredients of the study drug
- Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents
- Active or history of autoimmune diseases including autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, or thyroid disorders
- Systemic steroid or immunosuppressive therapy within 7 days before the first treatment dose, except stable or reduced low-dose corticosteroids for brain edema
- Active infections
- Risk of bleeding
- HIV positive status
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 2-week cycles until disease progression or discontinuation
Participants receive Camrelizumab 200mg once every 2 weeks, with each 4 weeks constituting one treatment cycle.
Visits every 2 weeks for treatment administration
Trial Site Locations
Total: 1 location
1
Sanbo Brain Hospital Capital Medical University
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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