Active — Not RecruitingPhase 2

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

South Korea28 participantsStarted 2022-08-18

Plain-language summary

Relapsed or refractory primary DLBCL of the CNS

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. 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)

✕. 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
✕. 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)

Objective response rate

Timeframe: Through study completion, an average of 1 year

NCT IDNCT05253118

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-28

Who can participate

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. 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)

✕. 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
✕. 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)