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

• Sponsor: Beijing Sanbo Brain Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04070040
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 34.6
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Central Nervous System Lymphoma	Drug: Camrelizumab	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Exploratory Study on Camrelizumab（SHR-1210）for Recurrent Primary Central Nervous System Lymphoma (PCNSL)
• Actual Study Start Date: Feb 13, 2020
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. ORR(objective response rate) [Up to three years]

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

Secondary Outcome Measures

1. The best therapeutic response of CR(complete response)、PR(partial response)、SD(stable response) and PD(progressive disease) [Up to three years]

   Describe the best therapeutic response of patients treated with Camrelizumab

2. PFS(progression free survival) [Up to three years]

   the time from randomization until objective tumor progression or death

3. OS(overall survival) [Up to three years]

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

4. ADEs( adverse events) [Up to three years]

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

5. KPS(Karnofsky Performance Status) [Up to three years]

   Duration of stabilization/improvement of Karnofsky Performance Status

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanbo Brain Hospital Capital Medical University	Beijing		China

Sponsors and Collaborators

• Beijing Sanbo Brain Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Junping Zhang, Beijing Sanbo Brain Hospital, Beijing Sanbo Brain Hospital
• ClinicalTrials.gov Identifier: NCT04070040
• Other Study ID Numbers: 1.0
• First Posted: Aug 28, 2019
• Last Update Posted: Feb 11, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma

Study Results

No Results Posted as of Feb 11, 2022