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

• Status: Not yet recruiting
• Trial end date: 2027-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy of orelabrutinib combined with R-CHOP vs. R-CHOP alone in the treatment of treatment-naїve mantle cell lymphoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
• Treatments: Cyclophosphamide; Doxorubicin; Prednisone; Rituximab; Vincristine

Criteria

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.