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

Launched by BEIJING INNOCARE PHARMA TECH CO., LTD. · Sep 15, 2021

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ClinConnect Summary

This clinical trial is studying a new treatment option for patients with mantle cell lymphoma (MCL), a type of blood cancer. Researchers are comparing the effectiveness of a drug called orelabrutinib when combined with a standard treatment called R-CHOP (which includes other medications) against R-CHOP alone. The goal is to see if adding orelabrutinib can improve treatment outcomes for patients who have not received treatment before.

To be eligible for this trial, participants need to be between 65 and 80 years old, or between 60 and 65 years old and not eligible for a specific type of stem cell transplant. They must have a confirmed diagnosis of mantle cell lymphoma and have not received any prior treatment for it. Participants can expect to be closely monitored during the study and will need to provide informed consent before joining. This trial is currently recruiting participants, and it's important for interested individuals to discuss their eligibility with their healthcare provider.

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Eligibility 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.