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

NCT04425824 | Unknown Phase 2

• 1 other identifier: NCC2244
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Exploring the efficacy and safety of Toripalimab with Rituximab for treatment of relapsed refractory CD20 positive diffuse large B-cell lymphoma.

Conditions

Diffuse Large B-cell Lymphoma; Rituximab; Toripalimab

Keywords

DLBCL; CD20; Toripalimab; Rituximab

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate(ORR)

  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

  up to 24 months

• Progression Free Survival(PFS)

  From the date into this study to disease progression or death

  up to 24 months

Secondary Outcomes (2)

• To assessment of the safety events

  up to 24 months

• Assessment of the correlation between tumor cell PD-L1 expression intensity and efficacy

  up to 24 months

Other Outcomes (2)

• Analysis of the correlation between the ammount of T cells and NK cells around tumor cells

  up to 24 months

• Change in immune microenviroment at the time of initial diagnosis and relapse

  up to 24 months

Study Arms (1)

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.

Drug: Toripalimab combine with Rituximab

Interventions

Toripalimab combine with Rituximab 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).

Also known as: JS001 combine with rituxan

Toripalimab combine with Rituximab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

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

Beijing, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Yan Qin, doctor

CONTACT

13601282738; qinyan66@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 11, 2020
• Study Start: June 15, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

CN (1)