Clinical trial · Interventional
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
NCT06290817CI-TRIAL-00074642unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Orelabrutinib combined with R-CDOP regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Orelabrutinib combined with R-CDOP regimen
- description
- Participants will receive 150 mg of oral orelabrutinib once daily with R-CDOP on day 1 of each cycle (21 days)
- interventionNames
- Drug: Orelabrutinib combined with R-CDOP regimen
Primary outcomes (1)
- measure
- 2-year central nervous system relapse rate
- timeFrame
- up to 2 years
- description
- The proportion of patients with central nervous system recurrence within two years from enrollment accounted for all patients treated with drugs.
Secondary outcomes (7)
- measure
- Complete Response Rate
- timeFrame
- At the end of Cycle 3 and Cycle 6(each cycle is 21 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.