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Primary Central Nervous System LymphomaPhase 2NCT04070040

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

A Phase 2 study testing Camrelizumab in people with Primary Central Nervous System Lymphoma, run by Beijing Sanbo Brain Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Central Nervous System Lymphoma
What is being tested?
Camrelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteChina
Study dates
13 Feb 2020to 31 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%;
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  • 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;

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Sanbo Brain Hospital Capital Medical University

    Beijing

    Jun-ping Zhang, 86-010-62856783, doczhjp@hotmail.com

    Recruiting

Other trials in China

About this study

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

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

Read the 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.

Being tested
Camrelizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CamrelizumabDrug

    Also called SHR-1210

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

Study groups in NCT04070040
Study groupRoleWhat they receive
CamrelizumabExperimentalCamrelizumab(SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle.
Receives: Drug: Camrelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR(objective response rate)

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

    Measured: Up to three years

Secondary outcomes (5)

  1. 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

    Measured: Up to three years

  2. PFS(progression free survival)

    the time from randomization until objective tumor progression or death

    Measured: Up to three years

  3. OS(overall survival)

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

    Measured: Up to three years

  4. ADEs( adverse events)

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

    Measured: Up to three years

  5. KPS(Karnofsky Performance Status)

    Duration of stabilization/improvement of Karnofsky Performance Status

    Measured: Up to three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start13 Feb 2020
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04070040
Sponsor's protocol ID
1.0
Status last verified
Oct 2024
First submitted
25 Aug 2019
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab in people with Primary Central Nervous System Lymphoma, run by Beijing Sanbo Brain Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR(objective response rate) (time frame: Up to three years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04070040.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.

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