Camrelizumab for Patients with Recurrent Primary Central Nervous System Lymphoma (PCNSL)

An Exploratory Study on Camrelizumab（SHR-1210）for Recurrent Primary Central Nervous System Lymphoma (PCNSL)

This study is intend to improve the objective response rate in treatment of camrelizumab in recurrent primary central nervous system lymphoma patients.

Study Overview

• Status: Recruiting
• Conditions: Primary Central Nervous System Lymphoma
• Intervention / Treatment: Drug: Camrelizumab

Detailed Description

Primary CNS lymphoma (PCNSL) is a rare B-cell variant of non-Hodgkin lymphoma that is confined to the brain, leptomeninges, spinal cord, and eyes. The optimum treatment for patients with recurrent PCNSL remains challenging and at present there is no universally accepted therapeutic approach . The purpose of this study is to evaluate the efficacy and safety of camrelizumab [a programmed cell death 1 (PD-1) inhibitor] for recurrent patients with primary CNS lymphoma.

• Study Type: Interventional
• Enrollment (Estimated): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Sanbo Brain Hospital Capital Medical University
    • Contact: Jun-ping Zhang; Phone Number: 86-010-62856783; Email: doczhjp@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The initial diagnosis was primary diffuse large B-cell lymphoma of the central nervous system confirmed by histopathology;
2. Prior to first-line treatment based on methotrexate (with or without radiotherapy), tumor recurrence was confirmed by MRI;
3. Measurable focus in MRI (>10x10mm);
4. Aged > 18 years;
5. Life expectancy of at least 12 weeks;
6. The patient has a Karnofsky performance status of at least 50%;
7. Main organs function normally, without serious blood, heart, lung, liver, kidney and immune deficiency diseases. Specific assay indicators requirements： White blood cells>3.0×10^9/L;platelet>80×10^9/L;hemoglobin>10g/dL;serum bilirubin ≤ 1.5×ULN;ALT and AST ≤ 2×ULN;serum creatinine≤1.5mg/dL;
8. Female subjects of childbearing age must exclude pregnancy and are willing to use a medically approved high-efficiency contraceptive (eg, IUD, contraceptive or condom) during the study period and within 3 months of the last study drug administration;
9. The subject should be aware of the purpose of the study and the operations required by the study and volunteer to participate in the study before sign the informed consent form;

Exclusion Criteria:

1. Concurrent administration of any other antitumor therapy；
2. Allergic to the ingredients of research drugs；
3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent；
4. Any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, decreased thyroid function；
5. Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment, except for a maximum dose of 4 mg/day dexamethasone or equivalent doses of other corticosteroids or control of brain edema, which has been stable or decreased for at least 1 week prior to inclusion;
6. Active infection;
7. Risk of bleeding;
8. HIV positivity;
9. Pregnancy and lactation;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Camrelizumab; Camrelizumab(SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle.	Drug: Camrelizumab; Camrelizumab(SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle.; Other Names: SHR-1210

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR(objective response rate)	the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period	Up to three years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The best therapeutic response of CR(complete response)、PR(partial response)、SD(stable response) and PD(progressive disease)	Describe the best therapeutic response of patients treated with Camrelizumab	Up to three years
PFS(progression free survival)	the time from randomization until objective tumor progression or death	Up to three years
OS(overall survival)	the time from randomization until death from any cause and is measured in the intent-to-treat population	Up to three years
ADEs( adverse events)	Adverse events at each visit with the NCI CTCAE v5.0 used as a guide for the grading of severity.	Up to three years
KPS(Karnofsky Performance Status)	Duration of stabilization/improvement of Karnofsky Performance Status	Up to three years

Collaborators and Investigators

• Sponsor: Beijing Sanbo Brain Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 25, 2019
• First Submitted That Met QC Criteria: August 25, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No