Clinical Trials /

Sintilimab Plus R-CHOP as the First-line Treatment in Patients With Diffuse Large B-Cell Lymphoma.

NCT04023916

Description:

The purpose of this study is to evaluate the efficacy and safety of Sintilimab and R-CHOP regimen as the first-line treatment for DLBCL patients with TP53 mutation and PD-L1 positive.

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

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Sintilimab Plus R-CHOP as the First-line Treatment in Patients With Diffuse Large B-Cell Lymphoma.
  • Official Title: Phase II Study of Sintilimab Plus R-CHOP as the First-line Treatment for DLBCL Patients With TP53 Mutation and PD-L1 Positive.

Clinical Trial IDs

  • ORG STUDY ID: NCC2066
  • NCT ID: NCT04023916

Conditions

  • Diffuse Large B-Cell Lymphoma
  • Sintilimab
  • TP53 Mutation

Interventions

DrugSynonymsArms
Sintilimab-R-CHOPSintilimab-R-CHOP

Purpose

The purpose of this study is to evaluate the efficacy and safety of Sintilimab and R-CHOP regimen as the first-line treatment for DLBCL patients with TP53 mutation and PD-L1 positive.

Detailed Description

      This Phase II, open-label, single-center, non-randomized study will evaluate the safety and
      efficacy of induction treatment consisting of Sintilimab in combination with Rituximab plus
      chemotherapy (R-CHOP) as the first-line treatment in participants with DLBCL, followed by
      consolidation treatment with Sintilimab alone in patients who achieve CR at the end of
      induction.This study also aim to evaluate the correlation of clinical efficacy to the
      expression of PD-L1,PD-1,CD3,CD4,CD8,CD56,CD58,β2-MG,HLA-DR/DP/DQ and so on by
      immunohistochemical techniques.
    

Trial Arms

NameTypeDescriptionInterventions
Sintilimab-R-CHOPExperimentalParticipants with previously untreated DLBCL will receive rituximab and CHOP during Cycle 1 (21-day cycle) and Sintilimab, rituximab, and CHOP during Cycles 2-6 (21-day cycle) ,Sintilimab and rituximab during Cycles 6-8 (21-day cycle) , followed by Sintilimab from Cycles 9-14 (8-week cycle) during consolidation treatment.
  • Sintilimab-R-CHOP

Eligibility Criteria

        Inclusion Criteria:

          1. Diagnosed as diffuse large B-cell Lymphoma with positive CD20 results;

          2. Age between 18 to 70 years old;

          3. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG)
             0-2;

          4. No history of malignant tumors, having no tumor other than DLBCL at the time of
             enrollment;

          5. Life expectancy no less than 6 months;

          6. The patient or his/her attorney would be able to provide written consent for necessary
             examinations or procedures;

          7. Ann Arbor stage II ~ IV, or stage I with large mass (maximum diameter >7.5cm)

          8. previously untreated advanced DLBCL.

          9. At least one bi-dimensionally measurable lesion (greater than [>] 1.5 centimeters in
             its largest dimension by CT scan or magnetic resonance imaging)

         10. Availability of a representative tumor specimen and the corresponding pathology report
             for retrospective central confirmation of the diagnosis of DLBCL.

         11. Agree to remain abstinent or use contraceptive measures.

        Exclusion Criteria:

          1. History of autologous stem cell transplantation,radiotherapy or chemotherapy.

          2. History of other malignant tumors, except skin basal cell carcinoma and in situ
             cervical cancer;

          3. With uncontrolled cardiovascular/ cerebrovascular disease, coagulation disorders,
             connective tissue disease, severe infectious diseases;

          4. Lymphoma originated in the central nervous system;

          5. Left ventricular ejection fraction ≦50%;

          6. Abnormal lab results in enrollment:Neutrophil count: <1.5*10^9/L;Platelet count
             <75*10^9/L;AST or ALT >2 times the upper limit of normal level,AKP and total bilirubin
             >1.5 times the upper limit of normal level;serum creatinine >1.5 times the upper limit
             of normal level;

          7. Other uncontrolled medical conditions which the investigators think might influence
             the results of the trial;

          8. Patients with mental illnesses or other diseases that might not comply with the trial
             plan;

          9. Women during pregnancy or lactation;

         10. HIV positive patients;

         11. HbsAg (+) patients with HBV DNA(+), can be enrolled only when his/her HBV DNA turns
             negative; patients with HBsAg(-) HBcAb(+) can be enrolled only when his/her HBV DNA
             turns negative;
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:complete remission rate
Time Frame:every 3 months until 30 months after the last patient's enrollment.
Safety Issue:
Description:complete remission rate after treated by Sintilimab+ R-CHOP regimen.

Secondary Outcome Measures

Measure:overall survival
Time Frame:30 months after the last patient's enrollment
Safety Issue:
Description:from the date of inclusion to date of death, irrespective of cause
Measure:adverse events
Time Frame:from the date of first cycle of treatment to 30 months after last patient's enrollment
Safety Issue:
Description:any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Chinese Academy of Medical Sciences

Trial Keywords

  • DLBCL
  • Sintilimab
  • R-CHOP
  • TP53
  • PD-L1

Last Updated