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

NCT04070040 | Recruiting Phase 2

• 1 other identifier: 1.0
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Central Nervous System Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  Up to three years

• PFS(progression free survival)

  Up to three years

• OS(overall survival)

  Up to three years

• ADEs( adverse events)

  Up to three years

• KPS(Karnofsky Performance Status)

  Up to three years

Study Arms (1)

Camrelizumab

EXPERIMENTAL

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

Drug: Camrelizumab

Interventions

Camrelizumab DRUG

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

Also known as: SHR-1210

Camrelizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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；
• Active infection;
• Risk of bleeding;
• HIV positivity;
• Pregnancy and lactation;

Sponsors & Collaborators

• Beijing Sanbo Brain Hospital: lead

Study Sites (1)

Sanbo Brain Hospital Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Interventions

camrelizumab

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beijing Sanbo Brain Hospital

Study Record Dates

• First Submitted: August 25, 2019
• First Posted: August 28, 2019
• Study Start: February 13, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)