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

Primary Central Nervous System Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04070040
• Other study ID #: 1.0
• Status: Recruiting
• Phase: Phase 2
• Start date: February 13, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Beijing Sanbo Brain Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Lymphoma
• Primary Central Nervous System Lymphoma

Intervention

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

Locations

Country	Name	City	State
China	Sanbo Brain Hospital Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Sanbo Brain Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	PFS(progression free survival)	the time from randomization until objective tumor progression or death	Up to three years
Secondary	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
Secondary	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
Secondary	KPS(Karnofsky Performance Status)	Duration of stabilization/improvement of Karnofsky Performance Status	Up to three years