Combining Orelabrutinib with R-CDOP for high-risk DLBCL patients

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

This study is testing if combining a new drug called Orelabrutinib with a standard treatment can help high-risk patients with a type of lymphoma live longer without their cancer coming back.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Drugs / interventions: Orelabrutinib, Ibrutinib, Doxorubicin
• Locations: 6 sites (Zhejiang, Zhejiang and 5 other locations)
• Trial ID: NCT06290817 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of Orelabrutinib, a new generation BTK inhibitor, combined with the R-CDOP regimen in treating newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients who are at high risk of central nervous system (CNS) relapse. The study aims to improve event-free survival rates by targeting the B-cell receptor signaling pathway, particularly in patients with dual-expressing, non-germinal center B-cell like lymphomas. Participants will receive treatment every 21 days, and the study is designed as a multicenter, single-arm trial to assess the safety and effectiveness of this combination therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed CD20-positive DLBCL and a CNS-IPI score of 4 or higher.

Not a fit: Patients with evidence of CNS involvement or significant active cardiovascular disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with high-risk DLBCL by reducing the likelihood of CNS relapse.

How similar studies have performed: Other studies have shown promising results with BTK inhibitors in similar patient populations, suggesting potential for success with this novel approach.

Eligibility criteria

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.

Where this trial is running

Zhejiang, Zhejiang and 5 other locations

• Second Affiliated Hospital, School of Medicine, Zhejiang University — Zhejiang, Zhejiang, China (Recruiting)
• Huzhou Central Hospital — Huzhou, China (Recruiting)
• Affiliated hospital of Jiaxing University , the First Hospital of Jiaxing — Jiaxing, China (Recruiting)
• Affiliated hospital of Jiaxing University , the Second Hospital of Jiaxing — Jiaxing, China (Recruiting)
• Ningbo Medical Center LiHuili Hospital — Ningbo, China (Recruiting)
• Taizhou Hospital of Zhejiang — Taizhou, China (Recruiting)

Study contacts

• Study coordinator: Xibin Xiao

Conditions Diffuse Large B-cell Lymphoma