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 range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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