Orelabrutinib plus Pola-R-CHP as first-line treatment for intermediate- to high-risk DLBCL

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 interventional study evaluates the safety and effectiveness of orelabrutinib in combination with Pola-R-CHP as a first-line therapy for adults with intermediate- to high-risk diffuse large B-cell lymphoma. Participants receive orelabrutinib daily for 21 days per 21-day cycle, with Pola-R-CHP given every cycle for six cycles, followed by rituximab with orelabrutinib in cycles 7 and 8, and up to one year of orelabrutinib maintenance. The trial includes adults with measurable DLBCL, ECOG 0-2, and IPI 2-5, and excludes those with CNS involvement or certain transformed lymphomas. Primary goals focus on safety and preliminary efficacy of the combination in the first-line setting. Locations are at The First Affiliated Hospital of Xiamen University in Xiamen, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged ≥ 18 years;
2. Pathologically confirmed diffuse large B-cell lymphoma (DLBCL) by tumor tissue, with at least one measurable lesion, including DLBCL, not otherwise specified (GCB and non-GCB subtypes), DLBCL with MYC and BCL-2 rearrangements, and high-grade B-cell lymphoma;
3. No prior receipt of other anti-tumor treatments;
4. ECOG performance status 0-2;
5. IPI score 2-5, and patients with stage III-IV disease;
6. Life expectancy ≥ 6 months;
7. Voluntarily sign a written informed consent form.

Exclusion Criteria:

1. Lymphoma involving the central nervous system or leptomeningeal metastasis;
2. Transformed lymphoma, i.e., transformed from other types of lymphoma, such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia, or small B-cell lymphoma;
3. Primary mediastinal large B-cell lymphoma;
4. Burkitt lymphoma;
5. Left ventricular ejection fraction \< 50%;
6. Laboratory test values at screening: (unless caused by lymphoma);

   1. Neutrophils \< 1.5×10⁹/L;
   2. Platelets \< 75×10⁹/L;
   3. ALT or AST higher than 2 times the upper limit of normal, AKP and bilirubin higher than 1.5 times the upper limit of normal;
   4. Creatinine level higher than 1.5 times the upper limit of normal;
7. Patients with psychiatric disorders or other patients who are known or suspected to be unable to fully comply with the study protocol;
8. Pregnant or lactating women;
9. Known infection with human immunodeficiency virus (HIV), or active hepatitis B or C virus infection (positive result by polymerase chain reaction \[PCR\]). If a patient has a positive HBsAg test result, HBV DNA testing is required. If HBV DNA \< 10³ IU/ml, the patient can be enrolled. If the HBsAg test result is negative, but the HBcAb test is positive (regardless of HBsAb status), HBV DNA testing is also required. If HBV DNA \< 10³ IU/ml, the patient can be enrolled. If a patient is HCV antibody positive, HCV RNA is detected by PCR technology, and a positive result meets the exclusion criterion;
10. Need for continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers;
11. nability to swallow capsules or presence of diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial or complete intestinal obstruction;
12. Other concurrent and uncontrolled medical conditions that the investigator deems will affect the patient's participation in the study.

Where it's running

• the First Affiliated Hospital of Xiamen University
  Xiamen, Fujian, China Recruiting
• the First Affiliated Hospital of Xiamen University
  Xiamen, Fujian, China Recruiting

Study contacts

• Principal investigator: Bing Xu, PhD，MD — The First Affiliated Hospital of Xiamen University
• Study coordinator: Bing Xu, PhD，MD
• Email: xubingzhangjian@126.com
• Phone: 18750918842

Similar studies

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

• Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL

  This trial tests whether a gentler, first-line treatment (Polatuzumab Vedotin with Rituximab and reduced-dose chemo) helps older, frail patients with DLBCL stay disease-free longer.

  Recruiting Phase 4 The First Hospital of Jilin University · Changchun, Jilin · NCT07908888

• 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

• Epcoritamab plus dose‑adjusted EPOCH‑R for aggressive B‑cell lymphoma

  This trial tests whether adding epcoritamab to dose‑adjusted EPOCH‑R chemotherapy can safely improve outcomes for adults with untreated aggressive B‑cell non‑Hodgkin lymphoma.

  Recruiting Phase 2 University of Washington · Seattle, Washington · NCT07097363

• Treatment for Richter Syndrome using Glofitamab with Rituximab or Obinutuzumab plus CHOP

  This study is testing if a new treatment combining Glofitamab with Rituximab or Obinutuzumab and CHOP chemotherapy can help people with untreated Richter Syndrome feel better.

  Recruiting at 6 sites Phase 2 French Innovative Leukemia Organisation · Amiens and 22 other locations · NCT06186648

• Treatment for Primary Mediastinal Large B-cell Lymphoma with Antibody Therapy and ImmunoChemotherapy

  This study is testing a new combination of antibody therapy and chemotherapy to see if it helps people with untreated primary mediastinal large B-cell lymphoma feel better and improve their quality of life.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT04745949

• Combining pomalidomide, rituximab, orelabrutinib and polatuzumab vedotin for elderly diffuse large B‑cell lymphoma

  This tests whether adding polatuzumab vedotin to a pomalidomide, rituximab and orelabrutinib regimen helps patients aged 70 and older with newly diagnosed diffuse large B‑cell lymphoma.

  Recruiting The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07072208

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.