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

Korábbi kezelés

• History of stroke or intracranial hemorrhage within 6 months before first administration of study treatment.

Más betegség

• Uncontrolled or significant cardiovascular diseases
• 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.

Egyéb

• 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.

• 65 < 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.