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Recruiting Phase 2

Orelabrutinib Combined With Pola-R-CHP Regimen for the Treatment of Untreated Non-GCB Diffuse Large B-Cell Lymphoma

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About this study

Assess the preliminary efficacy and safety of orelabrutinib in combination with the Pola-R-CHP regimen for the treatment of treatment-naive Non-GCB diffuse large B-cell lymphoma.

Condition
Diffuse Large B-Cell Lymphoma (DLBCL)
Tested
orelabrutinib combined with the Pola-R-CHP regimen
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine

Who can join

Age
18 to 80 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 18 years
  • Maximum age: 80 years
  • Study condition: Diffuse Large B-Cell Lymphoma (DLBCL)
  • Age 18 to 80 years old.
  • Diffuse large B-cell lymphoma (DLBCL) confirmed by tumor tissue pathology, with at least one measurable lesion.
  • Non-GCB.
  • No prior anti-tumor treatment.
  • ECOG score of 0-2.
  • Life expectancy of ≥6 months.
  • Voluntary written informed consent.

Exclusion 20

  • Lymphoma involving the central nervous system or leptomeningeal metastasis.
  • Transformed lymphoma, that is, transformed from other types of lymphoma, such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia, or small B-cell lymphoma.
  • Primary mediastinal large B-cell lymphoma.
  • Burkitt lymphoma.
  • Laboratory values at screening (unless due to lymphoma):
  • Neutrophils \<1.5×10⁹/L;
  • Platelets \<75×10⁹/L;
  • ALT or AST more than 2 times the upper limit of normal, ALP and bilirubin more than 1.5 times the upper limit of normal;
  • Creatinine level more than 1.5 times the upper limit of normal.
  • Patients with psychiatric disorders or other known or suspected inability to fully comply with the study protocol.
  • Pregnant or breastfeeding women.
  • Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C virus infection (positive result by polymerase chain reaction \[PCR\]).
  • If the patient tests positive for HbsAg, HBV DNA testing is required.
  • If HBV DNA \<10³ IU/ml, the patient may be enrolled.
  • If the patient tests negative for HbsAg but positive for HBcAb (regardless of HBsAb status), HBV DNA testing is also required.
  • If the patient tests positive for HCV antibody, HCV RNA is detected by PCR.
  • If positive, the patient meets the exclusion criteria.
  • Need for continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers.
  • Inability to swallow capsules or significant gastrointestinal disorders, such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial or complete intestinal obstruction.
  • Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study.

Where

1 site, 1 recruiting

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.