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Application of Zanubrutinib-based Combination Regimens in the Treatment of Newly-diagnosed Diffuse Large B-cell Lymphoma

RecruitingPhase 2Ages 18 Years - anyAllBeijing Tongren Hospital
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In plain words

What the trial is, and whether it could suit you

Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma. Currently, the first-line treatment regimen based on R-CHOP can only achieve clinical cure for 50% to 60% of patients. Previous studies have shown that patients with high-risk factors have a poor response to R-CHOP treatment and need further improvement. These high-risk factors include: IPI score ≥2 points, ABC subtype, double-expressing 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. Patients with DLBCL accompanied by high-risk factors also have a significantly increased risk of secondary CNS infiltration during recurrence. In previous RCHOP+X research strategies,

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📋 Eligibility rules (as published)
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.
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What it tests

  • Zanubrutinib+Pola-R-CHP
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Where

1 site
Beijing Tongren Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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