UnknownPhase 2

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

30 participantsStarted 2019-12-01

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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;

What they're measuring

complete remission rate

Timeframe: every 3 months until 30 months after the last patient's enrollment.

Trial details

NCT IDNCT04023916

SponsorChinese Academy of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-30

Contact for this trial

Yuankai Shi, M.D

86 010-87788293 syuankaipumc@126.com

View on ClinicalTrials.gov More Diffuse Large B-Cell Lymphoma trials