Clinical trial · Interventional
Orelabrutinib Combined With Rituximab and Chemotherapy for Relapsed/Refractory B-Cell Lymphoma Patients With Central Nervous System Involvement
NCT05926427CI-TRIAL-00069301unknownPhase 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 single-center, open, single-arm study aim to evaluate the efficacy and tolerability of a therapy introducing orelabrutinib on the basis of rituximab and chemotherapy in treating patients with relapsed or refractory B-cell lymphoma invloving central nervous system.
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 |
|---|---|---|---|
| CNS Lymphoma | Central Nervous System Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Orelabrutinib | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OR-chemo
- description
- Drug: Orelabrutinib, Rituximab and recommended chemotherapy according to histopathologic type
- interventionNames
- Drug: Orelabrutinib
- Drug: Rituximab
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- At the end-of-therapy response evaluation, 6 weeks after the end of Cycle 6, each cycle lasting 4 weeks
- description
- The ORR is defined as percentage of participants with overall response including complete response (CR) and partial response (PR), on the basis of investigator assessments, according to 2014 Lugano criteria.
Secondary outcomes (1)
- measure
- 2-year Progression-Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 14 to 80 years old; * Histopathologically confirmed CD20 positive B-cell lymphoma according to the 5th edition of the World Health Organization (WHO) Classification of Haematolymphoid Tumours; * After systemic treatment of the CNS lesions; * Life expectancy of \> 3 months (in the opinion of the investigator); * No non-haematologic adverse events, except alopecia, higher than grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0; * Absolute Neutrophil Count (ANC) ≥ 1.0×10\^9/L, Platelet Count ≥ 50×10\^9/L and Haemoglobin ≥ 60 g/L, without transfusion or any use of pharmacologically hematopoietic drugs in 2 weeks; * Serum Creatinine (SCr) ≤ 1.5 times the Upper Limit of Normal (ULN) or Creatinine Clearance Rate (CCR) ≥ 30 mL/min; * Serum total Bilirubin (tBil) ≤ 1.5 × ULN and both Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 × ULN without hepatic metastases, otherwise tBil ≤ 3 × ULN and AST, ALT ≤ 5 × ULN respectively; * International Normalized Ratio (INR) ≤ 1.5 and activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN; * Left Ventricular Ejection Fraction (LVEF) ≥ 50%; * Agreeing to provide written informed consent prior to any special examination or procedure for the research on their own or legal representative. Exclusion Criteria: * Pregnant or lactating women; * Known Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection (HBV infection refers to HBV-DNA \> detectable limit); * With acquired or congenital immunodeficiency; * With congestive heart failure in 6 months before enrollment, New York Heart Association (NYHA) heart function class III or IV, or LVEF \< 50%; * Known to be allergic to the test drug ingredients; * Diagnosed with or being treated for malignancy other than lymphoma; * With severe infection; * Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results; * Deemed unsuitable for the group.
References
Publications (0)
Data not yet available
No reference posted for this study.