Toripalimab Combine With Rituximab for Treatment of Relapsed Refractory CD20 Positive Diffuse Lar… (NCT04425824) | Clinical Trial Compass
UnknownPhase 2
Toripalimab Combine With Rituximab for Treatment of Relapsed Refractory CD20 Positive Diffuse Large B-cell Lymphoma
China20 participantsStarted 2020-06-15
Plain-language summary
Exploring the efficacy and safety of Toripalimab with Rituximab for treatment of relapsed refractory CD20 positive diffuse large B-cell lymphoma.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years old;
✓. According to the WHO 2016 classification criteria, the CD20 positive diffuse large B-cell lymphoma (DLBCL) diagnosed by pathology should include the indicators of immunohistochemistry: CD10, BCL-2, MUM-1, BCL-6 and C-MYC;
✓. Relapsed or refractory DLBCL.Patients younger than 65 years should relapse or progress after receiving at least second-line treatment, and patients 65 years of age and older could be intolerant to second-line treatment, and they who relapse or progress after receiving first-line treatment;
✓. There is at least one measurable lesion, defined as measurable dual-diameter, intra-lymph node lesion, short diameter\> 1.5cm, extra-lymph node lesion short diameter\> 1.0cm;
✓. Recurrence confirmed by pathological biopsy and CD20 positive;
✓. ECOG score 0-2 points;
✓. No autoimmune diseases;
✓. Blood routine examination meets the following criteria:
Exclusion criteria
✕. Diagnosed as transformed diffuse large B-cell lymphoma;
✕. Diagnosed as double-hit diffuse large B-cell lymphoma (DHL);
✕. Diagnosed as primary or secondary central nervous system lymphoma;
✕. Patients with history of autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, ankylosing spondylitis
✕. Patients are using or have been used immunosuppressive drugs