Clinical Trials /

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

NCT04425824

Description:

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

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
Toripalimab combine with RituximabJS001 combine with rituxanToripalimab 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

NameTypeDescriptionInterventions
Toripalimab combine with RituximabExperimentalExperimental: 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 12, 2020