RecruitingPhase 2NCT06290817

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

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

62 participants

Start Date

Mar 30, 2023

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Lymphoma

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

Min Age: 18 Years

Inclusion Criteria7

Age ≥18 years old; ECOG score 0-3;
Histologically confirmed diffuse large B-cell lymphoma, including DLBCL and transformed DLBCL;
CNS-IPI≥4 points
Previously untreated participants with CD20-positive DLBCL,;
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%.
At least one measurable lesion.
Have the sufficient understanding ability and voluntarily sign informed consent.

Exclusion Criteria8

Patients with evidence of CNS involvement ;
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;
Human immunodeficiency virus (HIV) infection;
Pregnant or lactating women;
Other tumors that require treatment;
Uncontrolled active infection;
The HBV DNA copy number of active hepatitis after antiviral treatment can not be controlled within 2×103/ml.
unable to understand and follow the research protocol or unable to sign the informed consent.

Interventions

DRUGOrelabrutinib combined with R-CDOP regimen

All participants were treated with the orelabrutinib combined with R-CHOP regimen (O-RCDOP). The treatment plan involved orelabrutinib tablets at 150mg QD (once daily) from day 1 to day 21, Rituximab at 375mg/m2 on day 1; Cyclophosphamide at 750mg/m2 on day 1; Liposomal Doxorubicin at 30mg/m2 on day 0; Vincristine at 25mg/m2 on day 1 (maximum dose 40mg); and Prednisone at 100mg from day 1 to day 5. The treatment cycles were set every 21 days for a total of 6-8 cycles. Dose adjustments were made for elderly patients for Cyclophosphamide and Liposomal Doxorubicin based on age: 70-80% of the dose for those aged 70-80 years old, and 50-60% of the dose for those older than 80 years.