Orelabrutinib Combined With R-CDOP for DLBCL Patients With High-risk of CNS Relapse Defined by CNS-IPI

Summary

This is a prospective, multicenter, single-arm clinical study on the treatment of newly diagnosed diffuse large B-cell lymphoma with high-risk of CNS relapse defined by CNS-IPI using Orelabrutinib in combination with R-CDOP regimen.

Eligibility

Inclusion Criteria:

1. Age ≥18 years old; ECOG score 0-3;
2. Histologically confirmed diffuse large B-cell lymphoma, including DLBCL and transformed DLBCL;
3. CNS-IPI≥4 points
4. Previously untreated participants with CD20-positive DLBCL,;
5. Heart, liver, and kidney function: creatinine \< 2 times the normal upper limit (ULN); ALT (alanine aminotransferase)/AST (Aspartate Aminotransferase) \< 2.5ULN; Total bilirubin \< 2ULN; Cardiac ejection fraction (EF) ≥50%.
6. At least one measurable lesion.
7. Have the sufficient understanding ability and voluntarily sign informed consent.

Exclusion Criteria:

1. Patients with evidence of CNS involvement ;
2. Clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional scale, or a history of myocardial infarction within 6 months before screening;
3. Human immunodeficiency virus (HIV) infection;
4. Pregnant or lactating women;
5. Other tumors that require treatment;
6. Uncontrolled active infection;
7. The HBV DNA copy number of active hepatitis after antiviral treatment can not be controlled within 2×103/ml.
8. unable to understand and follow the research protocol or unable to sign the informed consent.

Conditions2

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