Status:
UNKNOWN
Sintilimab Plus R-CHOP as the First-line Treatment in Patients With Diffuse Large B-Cell Lymphoma.
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Diffuse Large B-Cell Lymphoma
Sintilimab
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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.
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-...
Eligibility Criteria
Inclusion
- Diagnosed as diffuse large B-cell Lymphoma with positive CD20 results;
- Age between 18 to 70 years old;
- World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2;
- No history of malignant tumors, having no tumor other than DLBCL at the time of enrollment;
- Life expectancy no less than 6 months;
- The patient or his/her attorney would be able to provide written consent for necessary examinations or procedures;
- Ann Arbor stage I\~ IV
- previously untreated advanced DLBCL.
- At least one bi-dimensionally measurable lesion (greater than \[\>\] 1.5 centimeters in its largest dimension by CT scan or magnetic resonance imaging)
- Availability of a representative tumor specimen and the corresponding pathology report for retrospective central confirmation of the diagnosis of DLBCL.
- Agree to remain abstinent or use contraceptive measures.
Exclusion
- History of autologous stem cell transplantation,radiotherapy or chemotherapy.
- History of other malignant tumors, except skin basal cell carcinoma and in situ cervical cancer;
- With uncontrolled cardiovascular/ cerebrovascular disease, coagulation disorders, connective tissue disease, severe infectious diseases;
- Lymphoma originated in the central nervous system;
- Left ventricular ejection fraction ≦50％;
- 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;
- Other uncontrolled medical conditions which the investigators think might influence the results of the trial;
- Patients with mental illnesses or other diseases that might not comply with the trial plan;
- Women during pregnancy or lactation;
- HIV positive patients;
- 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;
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04023916
Start Date
December 1 2019
End Date
July 30 2021
Last Update
December 11 2019
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