Description:
Exploring the efficacy and safety of Toripalimab with Rituximab for treatment of relapsed
refractory CD20 positive diffuse large B-cell lymphoma.
Title
- Brief Title: Toripalimab Combine With Rituximab for Treatment of Relapsed Refractory CD20 Positive Diffuse Large B-cell Lymphoma
- Official Title: Toripalimab Combine With Rituximab for Treatment of Relapsed Refractory CD20 Positive Diffuse Large B-cell Lymphoma: An Exploratory Small Sample, Phase II, Single-center Clinical Trail
Clinical Trial IDs
- ORG STUDY ID:
NCC2244
- NCT ID:
NCT04425824
Conditions
- Diffuse Large B-cell Lymphoma
- Rituximab
- Toripalimab
Interventions
Drug | Synonyms | Arms |
---|
Toripalimab combine with Rituximab | JS001 combine with rituxan | Toripalimab combine with Rituximab |
Purpose
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). Rituximab is an antibody to CD20 molecules. One of the mechanisms of
killing tumor cells is through antibody-dependent cell-mediated cytotoxicity (ADCC). These
two drugs may have a synergistic effect on anti-tumor. The purpose of this study is to
determine whether Toripalimab with Rituximab is effective and safe for treatment of relapsed
refractory CD20 positive diffuse large B-cell lymphoma. This is an exploratory small sample,
phase II, single-center clinical trial, which is going to enroll 20 participants.
Trial Arms
Name | Type | Description | Interventions |
---|
Toripalimab combine with Rituximab | Experimental | Experimental: Toripalimab combine with Rituximab
Induction period:
Toripalimab 240mg administered intravenously (IV) on Day 1 of each 21-day cycle for 6 cycles.
Rituximab 375mg/m² administered intravenously (IV) on Day 1 of each 21-day cycle for 6 cycles.
Maintenance:
Toripalimab 240mg administered intravenously (IV) and Rituximab 375mg/m² on Day 1 of each 56-day cycle for 6 cycles. | - Toripalimab combine with Rituximab
|
Eligibility Criteria
Inclusion Criteria:
1. Age ≥18 years old;
2. 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;
3. 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;
4. 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;
5. Recurrence confirmed by pathological biopsy and CD20 positive;
6. ECOG score 0-2 points;
7. No autoimmune diseases;
8. Blood routine examination meets the following criteria:
1. Neutrophil count ≥ 1.5 x 109 / L,;
2. Platelet ≥ 75 x 109 / L,;
3. Hemoglobin ≥ 10.0 g / dL;
9. The main organ function meets the following criteria:
1. Aspartate aminotransferase and alanine aminotransferase ≤ 2.0 times the upper
limit of normal value;
2. Bilirubin ≤ 2.0 mg / dL;
3. Creatinine clearance rate ≥ 60 mL / min;
10. Patients must agree to take effective contraceptive measures during the study
according to the investigator's request;
11. Understand and voluntarily sign written informed consent.
Exclusion Criteria:
1. Diagnosed as transformed diffuse large B-cell lymphoma;
2. Diagnosed as double-hit diffuse large B-cell lymphoma (DHL);
3. Diagnosed as primary or secondary central nervous system lymphoma;
4. HBV DNA positive or HCV RNA positive patients;
5. Left ventricular ejection fraction <50%;
6. Patients with history of autoimmune diseases, including but not limited to systemic
lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, ankylosing spondylitis
7. Patients are using or have been used immunosuppressive drugs
8. Patients with ≥2 grade peripheral neuropathy
Maximum Eligible Age: | 80 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective Response Rate(ORR) |
Time Frame: | up to 24 months |
Safety Issue: | |
Description: | From the beginning of treatment, adopt Lugano 2014 evaluation standard, imaging examinations are performed every 2 cycles to assess changes in disease until progression or death |
Secondary Outcome Measures
Measure: | To assessment of the safety events |
Time Frame: | up to 24 months |
Safety Issue: | |
Description: | Number of subjects experiencing different-grade toxicity |
Measure: | Assessment of the correlation between tumor cell PD-L1 expression intensity and efficacy |
Time Frame: | up to 24 months |
Safety Issue: | |
Description: | Subjects will be according to the Lugano 2014 criteria assessed with computed tomograph(CT) at screening,after completion of treantment therapy and during the post-treatment follow-up period.Baseline biopsies for immunologic analyses will be obtained from patients. Secondary histologic outcome include percent PD-L1 positive tumor cells by immunohistochemistry. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Chinese Academy of Medical Sciences |
Trial Keywords
- DLBCL
- CD20
- Toripalimab
- Rituximab
Last Updated
June 16, 2020