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DLBCLPhase 2SPECTRUMNCT05253118

Relapsed or Refractory Primary Diffuse Large B-cell Lymphoma (DLBCL) of the Central Nervous System (CNS)

A Phase 2 study testing Tislelizumab and Pemetrexed in people with DLBCL, run by Seoul National University Hospital at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Relapsed or refractory primary DLBCL of the CNS Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
DLBCL
What is being tested?
Tislelizumab and Pemetrexed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteSouth Korea
Study dates
18 Aug 2022to 28 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
  • Age of 19 years or older on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place)
  • Histologically confirmed primary DLBCL of the CNS in the local lab
  • Relapsed or refractory disease with failure to at least one line of chemotherapy including high-dose methotrexate-containing regimen
  • At least one bi-dimensionally measurable lesion per IPCG response criteria Note: A lesion in an area subjected to prior locoregional therapy, including previous radiotherapy, is not considered measurable unless there has been demonstrated progression after the therapy as defined by IPCG response criteria.
  • Mandatory provision of next-generation sequencing (NGS) data or formalin-fixed paraffin-embedded (FFPE) archival tissue Note: Patients should submit 2 unstained slides and at least 5 cuts of tissue in 10-μm thickness. If there is local NGS data, at least 2 unstained slides are acceptable.
Show all 14Show fewer
  • ECOG performance status 0-2
  • Adequate organ function as indicated by the following laboratory values, ≤ 28 days prior to randomization or first dose of study drug(s)
  • Patients must not have required a blood transfusion or growth factor support ≤ 14 days before sample collection at screening for the following: i. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L ii. Platelets ≥ 75 x 109/L iii. Hemoglobin ≥ 90 g/L (9.0 g/dL)
  • Serum creatinine ≤ 1.5 x ULN (upper limit of normal) or estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation
  • Serum total bilirubin ≤ 1.5 x ULN (total bilirubin must be < 3 x ULN for patients with Gilberts syndrome).
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN if no demonstrable liver metastases, or ≤ 5 x ULN if transaminase elevation is attributable to liver metastases
  • Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 120 days after the last dose of study drug(s), and have a negative urine (or serum) pregnancy test ≤ 7 days before initial treatment
  • Non-sterile males must be willing to use a highly effective method of birth control and not donate/bank sperm for the duration of the study and for ≥ 120 days after the last dose of tislelizumab (a 'sterile' male is defined as one for whom azoospermia has been previously demonstrate in a semen sample examination as definitive evidence of infertility)

Who cannot join

  • Secondary CNS lymphoma
  • Primary ocular lymphoma
  • A known history of HIV infection
  • Previous treatment with pemetrexed or immunotherapy including, but not limited to anti-PD-(L)1 antibody and anti-CTLA4 antibody
  • Radiotherapy to CNS lesions within 4 weeks prior to initiation of study treatment
  • Autologous stem cell transplantation as a part of treatment for primary DLBCL of the within 90 days prior to the start of the treatment
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  • Has received any chemotherapy, targeted therapy, or any investigational therapies including investigational vaccine within 14 days or 5 half-lives (whichever is shorter) of the first study drug(s) administration
  • Known hypersensitivity or intolerance to pemetrexed or tislelizumab (BGB-A317)
  • Active autoimmune diseases or history of autoimmune diseases that may relapse
  • Note: Patients with the following diseases are not excluded and may proceed to further screening:
  • Controlled Type I diabetes
  • Hypothyroidism (provided it is managed with hormone replacement therapy only)
  • Controlled celiac disease
  • Skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia)
  • Any other disease that is not expected to recur in the absence of external triggering factors
  • Any active malignancy ≤ 2 years before the first dose of study drug(s), except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
  • Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s)
  • Note: Patients who are currently or have previously been on any of the following steroid regimens are not excluded:
  • Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)
  • Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption
  • Short course (≤ 7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non-autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact allergen)
  • With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
  • With severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infection, etc.
  • Severe infections within 4 weeks before the first dose of study drug(s), including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Received therapeutic oral or intravenous antibiotics within 2 weeks before the first drug administration
  • Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is > 20 IU/mL Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA < 20 IU/mL) can be enrolled. Patient taking antiviral agents should have received it more than 2 weeks before the treatment.
  • Patients with active hepatitis C virus (HCV) Note: Hepatitis C antibody (anti-HCV) is negative or anti-HCV positive with undetectable HCV RNA (< 15 IU/mL) can be enrolled. Patient taking antiviral agents should have received it more than 2 weeks before the treatment.
  • Any major surgical procedure requiring general anesthesia ≤ 28 days before the first dose of study drug(s)
  • Any of the following cardiovascular risk factors:
  • Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before the first dose of study drug(s)
  • Pulmonary embolism ≤ 28 days before the first dose of study drug(s)
  • Any history of acute myocardial infarction ≤ 6 months before the first dose of study
  • Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV (Appendix 6) ≤ 6 months before the first dose of study drug(s)
  • Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before the first dose of study drug(s)
  • Any history of cerebrovascular accident ≤ 6 months before the first dose of study drug(s)
  • Uncontrolled hypertension: systolic pressure ≥ 160 mmHg or diastolic pressure ≥ 100 mmHg despite anti-hypertension medications ≤ 28 days before the first dose of study drug(s)
  • Any episode of syncope or seizure ≤ 28 days before the first dose of study drug(s)
  • Has received any herbal medicine used to control cancer within 14 days of the first study drug(s) administration.
  • Patients with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized, except for AEs not considered a likely safety risk (e.g., alopecia, neuropathy and specific laboratory abnormalities)
  • Was administered a live vaccine ≤ 4 weeks before the first dose of study drug(s) Note: Seasonal vaccines for influenza and SARS-CoV-2 (or COVID-19) are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.
  • Underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse or dependence that, will be unfavorable for the administration of study drug(s) or affect the explanation of drug toxicity or AEs or result in insufficient or might impair compliance with study conduct.
  • Concurrent participation in another therapeutic clinical study.
  • Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 120 days after the last dose of study drug(s)
  • History or current evidence of any condition or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

About this study

Official title: Phase II Study of Tislelizumab Plus Pemetrexed in Patients With Relapsed or Refractory Primary Diffuse Large B-cell Lymphoma (DLBCL) of the Central Nervous System (CNS)

Relapsed or refractory primary DLBCL of the CNS

Read the detailed description

This is a multi-center, open label, single arm, phase 2 study designed to evaluate efficacy and safety of tislelizumab (BGB-A317) in combination with pemetrexed in patients with R/R primary DLBCL of the CNS. Twenty-eight patients will be enrolled. Eligible participants will receive combination treatment until disease progression, unacceptable toxicity, or withdrawal of informed consent.

Conditions
DLBCL
Keywords
DLBCL, Tislelizumab, Pemetrexed, relapsed or refractory primary diffuse large B-cell lymphoma, R/R primary DLBCL
Medical subject headings
Recurrence

What participants receive

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

  • TislelizumabDrug

    Also called BGB-A317

    Tislelizumab (BGB-A317) 200mg will be administered on Day 1 of each 21-day cycle (once every 3 weeks) in combination with pemetrexed.

  • PemetrexedDrug

    Pemetrexed 500 mg/m2 will be administered on Day 1 of each 21-day cycle (once every 3 weeks).

Study groups in NCT05253118
Study groupRoleWhat they receive
TreatmentExperimentalTislelizumab (BGB-A317) 200mg will be administered on Day 1 of each 21-day cycle (once every 3 weeks) in combination with pemetrexed. And pemetrexed 500 mg/m2 will be administered on Day 1 of each 21-day cycle (once every 3 weeks).
Receives: Drug: Tislelizumab; Drug: Pemetrexed

What is being measured

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

  1. Objective response rate

    To evaluate objective response rate (ORR) of tislelizumab (BGB-A317) plus pemetrexed in R/R primary DLBCL of the CNS

    Measured: Through study completion, an average of 1 year

Secondary outcomes (3)

  1. Progression-free survival

    To evaluate progression-free survival (PFS), duration of response (DoR) and overall survival (OS) of tislelizumab plus pemetrexed in R/R primary DLBCL of the CNS

    Measured: Through study completion, an average of 1 year

  2. Safety and Tolerability

    To evaluate the safety and tolerability of tislelizumab plus pemetrexed based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) version 5.0

    Measured: Through study completion, an average of 1 year

  3. Overall survival

    The length of time from the date of the first treatment to the date of any death or last follow-up

    Measured: Through study completion, an average of 2 years

Timeline

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

  1. First posted23 Feb 2022
  2. Study start18 Aug 2022
  3. Primary completion28 Dec 2026 (estimated)
  4. Study completion28 Dec 2026 (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
Model description
Tislelizumab (BGB-A317) 200mg will be administered on Day 1 of each 21-day cycle (once every 3 weeks) in combination with pemetrexed. And pemetrexed 500 mg/m2 will be administered on Day 1 of each 21-day cycle (once every 3 weeks).
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05253118
Sponsor's protocol ID
SPECTRUM
Acronym
SPECTRUM
Status last verified
Apr 2026
First submitted
6 Feb 2022
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Not yet

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab and Pemetrexed in people with DLBCL, run by Seoul National University Hospital at 1 site in South Korea.

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 14 inclusion and 44 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: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. 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 South Korea. 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?

This study is still under way. Results are not available in the source record yet.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: Through study completion, an average of 1 year). 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 NCT05253118.

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 24 Apr 2026.

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