RecruitingPhase 3NCT05051891
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
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Enrollment
356 participants
Start Date
Dec 22, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
To evaluate the efficacy of orelabrutinib combined with R-CHOP vs. R-CHOP alone in the treatment of treatment-naїve mantle cell lymphoma.
Eligibility
Min Age: 60 YearsMax Age: 80 Years
Inclusion Criteria6
- \< age \<80, or 60 ≤ age ≤65 and is ineligible for autologous stem cell transplantation as assessed by the investigator
- 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.
- No previous systemic treatment for MCL.
- ECOG physical strength score is 0-2.
- Expected survival time \>6 months.
- Voluntary written informed consent prior to screening.
Exclusion Criteria5
- Uncontrolled or significant cardiovascular diseases
- History of stroke or intracranial hemorrhage within 6 months before first administration of study treatment.
- Any mental or cognitive impairments which may limit the subject 's understanding and execution of informed consent as well as study compliance;
- Pregnant or breastfeeding women and those who do not agree to take contraceptive measures.
- Conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator.
Interventions
DRUGOrelabrutinib and R-CHOP
Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
DRUGR-CHOP
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
Locations(22)
View Full Details on ClinicalTrials.gov
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NCT05051891