Clinical trial · Interventional
A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma
NCT05051891CI-TRIAL-00106833completedPhase 3ClinicalTrials.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)
To evaluate the efficacy of orelabrutinib combined with R-CHOP vs. R-CHOP alone in the treatment of treatment-naїve mantle cell lymphoma.
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 |
|---|---|---|---|
| Treatment-naїve Mantle Cell Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Orelabrutinib and R-CHOP | Drug | — | UNRESOLVED |
| R-CHOP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- the experimental group
- description
- Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
- interventionNames
- Drug: Orelabrutinib and R-CHOP
- type
- EXPERIMENTAL
- label
- The control group
- description
- R-CHOP
- interventionNames
- Drug: R-CHOP
Primary outcomes (1)
- measure
- PFS
- timeFrame
- Up to 6 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. 65 \< age \<80, or 60 ≤ age ≤65 and is ineligible for autologous stem cell transplantation as assessed by the investigator 2. Histopathological confirmed MCL and either expression of cyclin D1 or t (11;14) chromosomal translocation (in association with CD20). The verification will be based on central review of the local pathology report. 3. No previous systemic treatment for MCL. 4. ECOG physical strength score is 0-2. 5. Expected survival time \>6 months. 6. Voluntary written informed consent prior to screening. Exclusion Criteria: 1. Uncontrolled or significant cardiovascular diseases 2. History of stroke or intracranial hemorrhage within 6 months before first administration of study treatment. 3. Any mental or cognitive impairments which may limit the subject 's understanding and execution of informed consent as well as study compliance; 4. Pregnant or breastfeeding women and those who do not agree to take contraceptive measures. 5. Conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.