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New treatment option for Primary Central Nervous System Lymphoma
Official title Camrelizumab for Patients with Recurrent Primary Central Nervous System Lymphoma (PCNSL)
ClinicalTrials.gov ID: NCT04070040
What this study is testing
What is Camrelizumab?
Camrelizumab is an investigational medicine, being studied as a potential treatment for primary central nervous system lymphoma.
Also referred to as SHR-1210.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is intend to improve the objective response rate in treatment of camrelizumab in recurrent primary central nervous system lymphoma patients.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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;
You likely can't join 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...
- Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment, except for a...
- Active infection;
See the full eligibility 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...
- Female people 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...
- 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;
- 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...
- 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...
- Active infection;
- Risk of bleeding;
- HIV positivity;
- Pregnancy and lactation;
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.