RecruitingPhase 2

Orelabrutinib Combined With Standard Immunochemotherapy With or Without Autologous Hematopoietic Stem Cell Transplantation (Auto-HSCT) for Newly Diagnosed Diffuse Large B-cell Lymphoma (DLBCL)

China30 participantsStarted 2026-03-01

Plain-language summary

This study is a prospective, open-label, multicenter study in previously untreated participants with CD20-positive DLBCL. Orelabrutinib combined with standard immunochemotherapy with or without autologous hematopoietic stem cell transplantation (auto-HSCT) for newly diagnosed diffuse large B-cell lymphoma (DLBCL). The primary objective is to explore the 1-year progression-free survival (PFS) of orelabrutinib combined with standard immunochemotherapy with or without auto-HSCT in newly diagnosed DLBCL.

Who can participate

Age range

18 Years – 80 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

. Hemoglobin ≥90 g/L within 7 days prior to enrollment without packed red blood cell transfusion;
. Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L;
. Platelet count ≥75 × 10⁹/L.

Exclusion criteria

. Coagulation function: INR \> 1.5× the upper limit of normal (ULN); PT and APTT \> 1.5× ULN;
. Liver function: ALT or AST \> 2× ULN; ALP and bilirubin \> 1.5× ULN;
. Renal function: Creatinine \> 1.5× ULN; creatinine clearance \< 60 mL/min (estimated by the Cockcroft-Gault formula);

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

1 year Progression free survival (PFS)

Timeframe: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year

Trial details

NCT IDNCT07680933

SponsorThe Affiliated Hospital of Xuzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Feng Zhu

0516-85806985 frankfeng_2004@126.com

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