Toripalimab Combine With Rituximab for Treatment of Relapsed Refractory CD20 Positive Diffuse Large B-cell Lymphoma

NCT ID: NCT04425824

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2022-12-31

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). 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.

Conditions

Diffuse Large B-cell Lymphoma; Rituximab; Toripalimab

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Toripalimab combine with Rituximab

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.

Group Type: EXPERIMENTAL

Toripalimab combine with Rituximab

Intervention Type: DRUG

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).

Drug: Rituximab Rituximab is an antibody to CD20 molecules. One of the mechanisms of killing tumor cells is through antibody-dependent cell-mediated cytotoxicity (ADCC).

Interventions

Toripalimab combine with Rituximab

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).

Drug: Rituximab Rituximab is an antibody to CD20 molecules. One of the mechanisms of killing tumor cells is through antibody-dependent cell-mediated cytotoxicity (ADCC).

Intervention Type: DRUG

Other Intervention Names

JS001 combine with rituxan

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Shi Yuankai

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, , China

Countries

China

Central Contacts

Yan Qin, doctor

Role: CONTACT

qinyan66@vip.sina.com

13601282738

Facility Contacts

Yan Qin, doctor

Role: primary

qinyan66@vip.sina.com

13601282738

Other Identifiers

NCC2244

Identifier Type: -

Identifier Source: org_study_id