Clinical trial · Interventional
Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（Rocket Trial）
Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients: a Single-arm, Multicenter, Phase II Clinical Trial（Rocket Trial）
NCT06647940CI-TRIAL-00081836recruitingPhase 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, multicenter, phase II clinical trial to evaluate the efficacy and safety of orelabrutinib combined with the R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) regimen as first-line treatment in CD5-positive diffuse large B-cell lymphoma (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 (DLBCL) | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Orelabrutinib Oral Tablet | Drug | — | UNRESOLVED |
| R-CHOP Protocol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Orelabrutinib in combination with R-CHOP
- description
- Patients with CD5 positive diffuse large B-cell lymphoma will receive orelabrutinib in combination with R-CHOP regimen from the second cycle of R-CHOP (3 weeks per cycle). After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with orelabrutinib will be conducted.
- interventionNames
- Drug: Orelabrutinib Oral Tablet
- Drug: R-CHOP Protocol
Primary outcomes (1)
- measure
- 2-year event-free survival (EFS) rate
- timeFrame
- Defined as the proportion of patients without disease progression, treatment discontinuation, or death for any reason within 24 months of enrollment
- description
- To investigate the preliminary anti-tumor efficacy
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. Subjects fully understand and voluntarily participate in this study and sign informed consent. 2. Aged ≥18 years, both male and female. 3. Pathologically confirmed CD5-positive DLBCL 4. There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma. 5. Eastern Cooperative Oncology Group(ECOG) performance status score of 0-2. 6. Expected survival ≥3 months. 7. Sufficient bone marrow, liver, and kidney function. Key Exclusion Criteria: 1. DLBCL combined with other types of lymphoma. Transformed DLBCL. 2. DLBCL with central nervous system invasion. 3. The patients had previously received BTK inhibitors. 4. The patients have contraindications to any drug in the combined treatment. 5. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome. 6. Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug. 7. Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception. 8. Mentally ill persons or persons unable to obtain informed consent. 9. The investigators think that the patient is not suitable for the study.
References
Publications (0)
Data not yet available
No reference posted for this study.