Clinical trial · Interventional
Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL
A Phase 2 Study of Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL
NCT05498259CI-TRIAL-00063661unknownPhase 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)
The purpose of this study is to evaluate the efficacy and safety of orelabrutinib combined with rituximab,followed by orelabrutinib combined with R-CHOP-like regimen for newly diagnosed untreated Non-GCB DLBCL Patients
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CHOP-like Regimen | Drug | — | UNRESOLVED |
| Orelabrutinib | Drug | — | UNRESOLVED |
| Rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Orelabrutinib+R-CHOP-like
- description
- Orelabrutinib plus Rituximab for 21 days; Following Imaging examinations, patients with ≥25% tumor reduction, treat with orelabrutinib 150mg qd orally plus R-CHOP-like for 6 cycles; whereas, patients with \<25% tumor reduction, withdraw from the study,treat with R-CHOP-like alone for 6 cycle
- interventionNames
- Drug: Orelabrutinib
- Biological: Rituximab
- Drug: CHOP-like Regimen
Primary outcomes (1)
- measure
- Complete Response Rate
- timeFrame
- At the end of Cycle 6(each cycle is 21 days)
- description
- The rate of patients who achieved complete response after treatment by OR-CHOP-like
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed Non-GCB DLBCL 2. Age ≥18 and ≤70 years 3. At least one measurable lesion,measurable lymph nodes or masses of at least 15 millimeter (mm) 4. ECOG performance status 0-2 5. Lymphoma International Prognostic Score (IPI) ≥ 2 6. Life expectancy ≥ 6 months 7. Adequate organ and marrow function 8. Agreement to practice birth control from the time of enrollment until the follow-up period of the study Exclusion Criteria: 1. Received major surgery within 4 weeks before treatment or existed unhealed wounds or ulcers, except biopsy related to lymphoma diagnosis 2. All patients with primary central nervous system lymphoma 3. History of stroke or intracranial hemorrhage within 6 months before screening, require or receive anticoagulant therapy with warfarin or an equivalent antagonist 4. Requires treatment with strong /moderate CYP3A inhibitors or inducers 5. Uncontrolled comorbidity or complications, including but not limited to: symptomatic congestive heart failure (New York Heart Association Class III-IV) or symptomatic or poorly controlled arrhythmias and/or significant pulmonary disease 6. HIV infection and/or active hepatitis B or active hepatitis C infection 7. Uncontrolled active systemic infection 8. Known hypersensitivity or contraindications to any drug involved in the study 9. Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.