Status:
UNKNOWN
Toripalimab Combine With Rituximab for Treatment of Relapsed Refractory CD20 Positive Diffuse Large B-cell Lymphoma
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Diffuse Large B-cell Lymphoma
Rituximab
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Exploring the efficacy and safety of Toripalimab with Rituximab for treatment of relapsed refractory CD20 positive diffuse large B-cell lymphoma.
Detailed Description
Toripalimab is a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2). Ri...
Eligibility Criteria
Inclusion
- 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:
- Neutrophil count ≥ 1.5 x 109 / L,;
- Platelet ≥ 75 x 109 / L,;
- Hemoglobin ≥ 10.0 g / dL;
- The main organ function meets the following criteria:
- Aspartate aminotransferase and alanine aminotransferase ≤ 2.0 times the upper limit of normal value;
- Bilirubin ≤ 2.0 mg / dL;
- Creatinine clearance rate ≥ 60 mL / min;
- Patients must agree to take effective contraceptive measures during the study according to the investigator's request;
- Understand and voluntarily sign written informed consent.
Exclusion
- 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;
- HBV DNA positive or HCV RNA positive patients;
- Left ventricular ejection fraction \<50%;
- 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
- Patients with ≥2 grade peripheral neuropathy
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04425824
Start Date
June 15 2020
End Date
December 31 2022
Last Update
June 16 2020
Active Locations (1)
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1
Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, China