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

Primary Purpose

Primary Central Nervous System Lymphoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Camrelizumab

About this trial

This is an interventional treatment trial for Primary Central Nervous System Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The initial diagnosis was primary diffuse large B-cell lymphoma of the central nervous system confirmed by histopathology;
Prior to first-line treatment based on methotrexate (with or without radiotherapy), tumor recurrence was confirmed by MRI;
Measurable focus in MRI (>10x10mm);
Aged > 18 years;
Life expectancy of at least 12 weeks;
The patient has a Karnofsky performance status of at least 50%;
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;
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;
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:

Concurrent administration of any other antitumor therapy；
Allergic to the ingredients of research drugs；
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent；
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；
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;
Active infection;
Risk of bleeding;
HIV positivity;
Pregnancy and lactation;

Sites / Locations

Sanbo Brain Hospital Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Camrelizumab

Arm Description

Camrelizumab(SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle.

Outcomes

Primary Outcome Measures

ORR(objective response rate)

the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period

Secondary Outcome Measures

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

PFS(progression free survival)

the time from randomization until objective tumor progression or death

OS(overall survival)

the time from randomization until death from any cause and is measured in the intent-to-treat population

ADEs( adverse events)

Adverse events at each visit with the NCI CTCAE v5.0 used as a guide for the grading of severity.

KPS(Karnofsky Performance Status)

Duration of stabilization/improvement of Karnofsky Performance Status

Full Information

NCT ID

NCT04070040

First Posted

August 25, 2019

Last Updated

April 18, 2023

Sponsor

Beijing Sanbo Brain Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04070040

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 13, 2020 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Sanbo Brain Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Central Nervous System Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Camrelizumab

Arm Type

Experimental

Arm Description

Camrelizumab(SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle.

Intervention Type

Drug

Intervention Name(s)

Camrelizumab

Other Intervention Name(s)

SHR-1210

Intervention Description

Camrelizumab(SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle.

Primary Outcome Measure Information:

Title

ORR(objective response rate)

Description

the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period

Time Frame

Up to three years

Secondary Outcome Measure Information:

Title

The best therapeutic response of CR(complete response)、PR(partial response)、SD(stable response) and PD(progressive disease)

Description

Describe the best therapeutic response of patients treated with Camrelizumab

Time Frame

Up to three years

Title

PFS(progression free survival)

Description

the time from randomization until objective tumor progression or death

Time Frame

Up to three years

Title

OS(overall survival)

Description

the time from randomization until death from any cause and is measured in the intent-to-treat population

Time Frame

Up to three years

Title

ADEs( adverse events)

Description

Adverse events at each visit with the NCI CTCAE v5.0 used as a guide for the grading of severity.

Time Frame

Up to three years

Title

KPS(Karnofsky Performance Status)

Description

Duration of stabilization/improvement of Karnofsky Performance Status

Time Frame

Up to three years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The initial diagnosis was primary diffuse large B-cell lymphoma of the central nervous system confirmed by histopathology; Prior to first-line treatment based on methotrexate (with or without radiotherapy), tumor recurrence was confirmed by MRI; Measurable focus in MRI (>10x10mm); Aged > 18 years; Life expectancy of at least 12 weeks; The patient has a Karnofsky performance status of at least 50%; 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; 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; 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: Concurrent administration of any other antitumor therapy； Allergic to the ingredients of research drugs； Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent； 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； 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; Active infection; Risk of bleeding; HIV positivity; Pregnancy and lactation;

Facility Information:

Facility Name

Sanbo Brain Hospital Capital Medical University

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun-ping Zhang

Phone

86-010-62856783

doczhjp@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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