Clinical trial · Interventional
A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma
A Phase II, Prospective ,Multicenter Study Evaluating the Efficacy and Safety of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma
NCT05933967CI-TRIAL-00068836recruitingPhase 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 multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with R-CHOP in the treatment of treatment-naïve patients with double expression DLBCL.
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 |
|---|---|---|---|
| The First Affiliated Hospital of Nanchang University | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Orelabrutinib+R-CHOP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- orelabrutinib+R-CHOP
- interventionNames
- Drug: Orelabrutinib+R-CHOP
Primary outcomes (1)
- measure
- complete response rate
- timeFrame
- up to 24 weeks
Secondary outcomes (4)
- measure
- ORR
- timeFrame
- up to 24 weeks
- description
- ORR is defined as the proportion of patients with a best response of CR or PR
- measure
- 2 years progression-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed Double Expression Diffuse Large B-cell Lymphoma * Age 18-70 years * ECOG performance status 0-2 * Ann Arbor stage II-IV * 8.Subjects who in line with the testing standard of the clinical trial laboratory * Life expectancy ≥ 3months Exclusion Criteria: * • systemic lymphoma involved CNS. * Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases. * uncontrolled infections (including HBV, HCV, HIV/AIDS) * Subjects who prepared for transplantation * Pregnancy or active lactation
References
Publications (0)
Data not yet available
No reference posted for this study.