Zanubrutinib plus Pola-R-CHP for newly diagnosed high-risk diffuse large B‑cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, phase 2 trial gives treatment‑naive patients with measurable DLBCL and prespecified high‑risk features a combination regimen including zanubrutinib and Pola-R-CHP, with alternative backbone adjustments (for example rituximab plus high‑dose methotrexate) for certain CNS presentations. Eligible patients have at least one high‑risk factor such as IPI ≥2, ABC subtype, double‑expressor or double‑hit biology, CD5 positivity, MCD/N1/A53 subtypes, or multiple extranodal/special-site involvement. The study measures safety and anti‑lymphoma activity, focusing on response rates and progression‑free survival compared to historical outcomes with R‑CHOP. Treatment is administered and patients are followed at Beijing Tongren Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pathologically confirmed diffuse large B-cell lymphoma (DLBCL);
* Have a "measurable lesions" ;
* Have at least one of the following risk factors, including: IPI score ≥2 points, ABC subtype, double-expressor lymphoma, double-hit lymphoma, CD5-positive DLBCL, MCD subtype, N1 subtype, A53 subtype, extranodal lesions ≥2, special site involvement, such as central nervous system CNS, breast, testis, ovary, uterus, bone marrow, vitreoretinal, paraspinal, paranasal sinuses and intravascular, etc.
* ECOG score 0-3;
* Expected survival time for 3 months or more;
* White blood cell count ≥3 x 10e9/L, the platelet count≥50 x 10e9/L; 1.5 mg/dL or less of serum creatinine, creatinine clearance≥50 ml/min; ALT, AST 3 x ULN or less, total bilirubin 2 x ULN or less.

Exclusion Criteria (the subject should not have any one of the following):

* currently suffering from other malignant tumor;
* ever received any treatments for lymphoma, except for short-term use of corticosteroids;
* Allergic to any kind of study drug;
* Active infection or uncontrol of HBV infection, HIV/AIDS or other serious infectious diseases;
* Pregnancy and lactation women of childbearing age and are reluctant to take contraception subjects;
* Researchers think that the subject does not fit to participate in this study.

Where it's running

• Beijing Tongren Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Liang Wang, M.D.
• Email: wangliangtrhos@126.com
• Phone: +861058266633

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Polatuzumab vedotin with Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in untreated DLBCL (MCD/BN2/N1)

  This study tests a targeted combination therapy to see if it can treat previously untreated DLBCL with specific molecular subtypes.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07608978

• ctDNA testing in newly diagnosed DLBCL or HGBL to predict treatment outcomes

  This study checks if measuring circulating tumor DNA in blood after first-line therapy can predict whether the disease will stay away or come back in people with DLBCL or HGBL.

  Recruiting at 2 sites Peking University People's Hospital · Beijing, Beijing Municipality and 1 other locations · NCT07878351

• Zanubrutinib plus Lenalidomide for frail elderly with newly diagnosed PCNSL

  This study tests whether a combination of zanubrutinib and lenalidomide can help frail elderly patients with newly diagnosed primary CNS lymphoma.

  Recruiting Phase 2 Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT07839247

• Proton Therapy for Mediastinal Lymphoma in Denmark

  This study tests whether using proton therapy for mediastinal lymphoma can lower late-toxicity risk compared with photon therapy in adults.

  Recruiting Copenhagen University Hospital, Rigshospitalet · Copenhagen, Select A State · NCT07817641

• Memory-Enhanced CAR-T Therapy for Relapsed/Refractory Large B-Cell Lymphoma

  This trial tests memory-enhanced 7×19-THEMIS CAR-T cells in adults with relapsed or refractory large B-cell lymphoma to see how safe they are and whether tumors shrink or disappear.

  Recruiting Phase 1/2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07788118

• UB-VV400 with rapamycin in relapsed/refractory B-cell lymphomas

  A phase 1/2 trial tests UB-VV400 plus rapamycin in adults with relapsed or refractory B-cell lymphomas to see if it is safe and shows anti-tumor activity.

  Recruiting at 2 sites Phase 1/2 Umoja Biopharma · Irvine, California and 1 other locations · NCT07735533

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.