Clinical trial · Interventional
Zanubrutinib Combined With R-CHOP in Newly-diagnosed Intravascular Large B-cell Lymphoma
A Prospective Phase II Study of Zanubrutinib Combined With R-CHOP in Newly-diagnosed Intravascular Large B-cell Lymphoma
NCT04899570CI-TRIAL-00051960unknownPhase 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 single-arm phase II study, and the purpose of this study is to evaluate the efficiency of zanubrutinib combined with R-CHOP regimen in newly diagnosed primary intraocular lymphoma. Progression-free survival (PFS) of the cohort is the primary endpoint.
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 |
|---|---|---|---|
| Intravascular Large B-Cell Lymphoma | Intravascular Large B-Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vindesine | Drug | Vindesine | ALIAS |
| Zanubrutinib | Drug | Zanubrutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zanubrutinib combined with R-CHOP
- description
- The experimental arm will be treated zanubrutinib combined with R-CHOP regimen for 8 cycles. The interim evaluation will be performed after 4 cycles, and the patients who can't achieve PR or CR will be withdrawn from this trial and receive salvage regimens. After 8 cycles of ZR-CHOP, the patients will be followed for 2 years to evaluate the PFS.
- interventionNames
- Drug: Zanubrutinib
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Epirubicin
- Drug: Vindesine
- Drug: Prednisone
Primary outcomes (1)
- measure
- 2 years progression-free survival
- timeFrame
- from the date of treatment to the subject finished his 2 years follow-up phase or the disease relapsed or the death due to lymphoma
- description
- 2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow up without relapsing.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * The patient volunteered to participate in the study and signed the Informed Consent * Age ≥18 years old ≤70 Years old, male or female * Expected survival ≥ 12 weeks * Intravascular large B-cell lymphoma confirmed by cytology or histology according to WHO2016 criteria * Never received any anti-tumor therapies. * Adequate organ function and adequate bone marrow reserve Exclusion Criteria: * Malignant tumors other than IVLBCL within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery * Active HIV, HBV, HCV or treponema pallidum infection * Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy * Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after their cell transfusion * Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment
References
Publications (0)
Data not yet available
No reference posted for this study.