Clinical trial · Interventional
Phase II Study of Orelabrutinib Combined With PD-1 Inhibitor in Relapsed/Refractory Primary Central Nervous System Lymphoma
Orelabrutinib Combined With PD-1 Inhibitor in Relapsed/Refractory Primary Central Nervous System Lymphoma: a Prospective Multi-center Phase II Study
NCT04899427CI-TRIAL-00051957unknownPhase 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 phase II study, and the purpose of this study is to evaluate the efficiency of Orelabrutinib combined with PD-1 inhibitor regimen relapsed/refractory primary intraocular lymphoma. Overall response rate （ORR） after 4 cycles 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 |
|---|---|---|---|
| Primary Central Nervous System Lymphoma | Primary Central Nervous System Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| orelabrutinib | Drug | — | UNRESOLVED |
| Sintilimab | Drug | Sintilimab | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- orelabrutinib combined with PD-1 inhibitor
- description
- The experimental arm will be treated orelabrutinib plus PD-1(programmed death）inhibitor every 21 days as one cycle. The responses will be evaluated every 2 cycles during the first 6 cycles and every 3 months until progression. The investigators can choose Sintilimab Injection or Tislelizumab Injection at the beginning of treatment，but they can't exchange to another during the whole treatment.
- interventionNames
- Drug: orelabrutinib
- Drug: Sintilimab
- Drug: Tislelizumab
Primary outcomes (1)
- measure
- overall response rate
- timeFrame
- 3 weeks after the end of 4 cycles of induction (each cycle is 21 days)
- description
- ORR was calculated by the proportion of patients who achieved complete remission and partial remission.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years old ≤75 Years old, male or female * Primary Central nerves system lymphoma confirmed by cytology or histology according to WHO2016 criteria * No evidence of systemic lymphoma * Patients with a clear diagnosis of relapsed and/or refractory PCNSL: they received at least one regimen containing methotrexate. * At least one measurable lesion according to Lugano 2014 criteria * Adequate organ function and adequate bone marrow reserve Exclusion Criteria: * Malignant tumors other than B-NHL 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 * Any systemic antitumor therapy performed within 2 weeks before enrollment * Previous use of other BTK inhibitors or PD-1 inhibitors.
References
Publications (0)
Data not yet available
No reference posted for this study.