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

• Status: Not yet recruiting
• Trial end date: 2021-07-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences

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 I~ IV

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;